Acronyms of Clinical Trial Terms

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A

B

BARQA British Association of Research Quality Assurance BCE beneficial clinical event Glossary Acronyms, Abbreviations, and Initials December 2003 actmagazine.com APPLIED CLINICAL TRIALS 25 BDPA Bureau of Drug Policy and Administration (China) BEUC European Bureau of Consumer Unions BfArM Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices, Germany) BGA Bundesgesundheitsamt (Federal health office; former German public health agency) BGVV Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin (Federal Institute for Health Protection of Consumers and Veterinary Medicine, Germany) BIO Biotechnology Industry Organization BIRA British Institute of Regulatory Affairs BLA Biologics License Application (FDA) BPI Bundesverband der Pharmazeutischen Industrie EV (Germany) BrAPP British Association of Pharmaceutical Physicians BSA body surface area

C

CA Competent Authority (regulatory body charged with monitoring compliance with European Union member state national statutes and regulations) CAPRA Canadian Association of Pharmaceutical Regulatory Affairs CAS Chemical Abstracts Service CBER Center for Biologics Evaluation and Research (FDA) CCI Committee on Clinical Investigations. See also Ethics Committee box. CCPPRB Comité Consultative pour la Protection des Personnes dans les Recherches Biomédicales (France). See also Ethics Committee box. CCRA Certified Clinical Research Associate. Certification issued to monitors by ACRP. CCRC Certified Clinical Research Coordinator. Certification issued to clinical coordinators by ACRP. CCRP Certified Clinical Research Professional. SOCRA certification of coordinators, monitors, and other research professionals. CDC Centers for Disease Control and Prevention CDER Center for Drug Evaluation and Research (FDA) CDISC Clinical Data Interchange Standards Consortium (formerly a DIA special interest group called the Clinical Data Interchange Standards Committee) CDM clinical data management CDRH Center for Devices and Radiological Health (FDA) CEN Comité Européen de Normalisation (European Committee for Standardization) CEU continuing education unit CF consent form CFH Connecting for Health CFR Code of Federal Regulations (usually cited by title and part; for example, Title 21, Part 211 is shown as 21 CFR 211) 26 APPLIED CLINICAL TRIALS actmagazine.com December 2003 cGMP current good manufacturing practices CHI Consolidated Health Initiative (eGov) CHR Committee on Human Research. See also Ethics Committee box. CIOMS Council for International Organisations of Medical Sciences (postapproval international ADR reporting, UK) CIP Certified IRB Professional CIS Commonwealth of Independent States CLIA Clinical Laboratory Improvements Amendments Cmax concentration maximum; used in pharmacokinetics and bioequivalence to indicate maximum plasma concentration for a drug CMC chemistry, manufacturing, and control CME continuing medical education CNS central nervous system COP CDISC operating process/procedure COSTART Coding Symbols for a Thesaurus of Adverse Reaction Terms. See also MedDRA. CPHS Committee for the protection of human subjects CPMP Committee for Proprietary Medicinal Products (EU) CPSC Consumer Product Safety Commission (U.S.) CRA clinical research associate. See also CCRA CRADA cooperative research and development agreement (with NIH) CRB case record book CRB central review board CRC clinical research coordinator. See also CCRC, SC, SSC CRF case report form (sometimes case record form) CRO contract research organization. See also IPRO. CSDD Center for the Study of Drug Development CSF Collaborative Standards Forum (CDISC) CSM Committee on Safety of Medicines (UK) CSO Consumer Safety Officer (FDA) CSR clinical study report CSU clinical supply unit CT clinical trial CTC clinical trial certificate (UK) CTD common technical document 1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity. 2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature. 3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment. 4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. 5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects. 6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. 7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death. 8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. 9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible. 10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject. Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181–182. Washington, D.C.: U.S. Government Printing Office, 1949. Nuremberg Code—Directives for Human Experimentation December 2003 actmagazine.com APPLIED CLINICAL TRIALS 27 CTEP Clinical Therapeutics Evaluation Program (NCI) CTM clinical trials materials CTX clinical trial exemption (MCA) CV curriculum vitae CVM Center for Veterinary Medicine (FDA)

D

DAWN Drug Abuse Warning Network DD Department of Drugs (Swedish regulatory agency) DEA Drug Enforcement Administration (U.S.) DEN Drug Experience Network DES Data Encryption Standard DESI Drug Efficacy Study Implementation notice (FDA, to evaluate drugs in use before 1962) DGPharMed Deutsche Gesellschaft für Pharmazeutische Medizin (German Society of Pharmaceutical Medicine), formerly FÄPI DHEW Department of Health, Education and Welfare (U.S., now split into DHHS and Department of Education) DHHS Department of Health and Human Services (U.S.) DHTML dynamic HTML (IT) DIA Drug Information Association DICOM Digital Imaging and Communications in Medicine DLT dose-limiting toxicity DMB Data Management Biomedical (France) DoD Department of Defense (U.S.) DPC-PTR Act Drug Price Competition and Patent Term Restoration Act of 1984 (also Waxman-Hatch or Hatch-Waxman bill) DSI Division of Scientific Investigations (FDA) DSM Diagnostic and Statistical Manual (of the American Psychiatric Association) DSMB Data and Safety Monitoring Board DSNP development of standardized nomenclature project (FDA) DTC direct-to-consumer (drug advertising) DTD document type definition (XML)

E

E3C European CDISC Coordinating Committee EAB Editorial Advisory Board (Applied Clinical Trials) EAB Ethical advisory board. See also Ethics Committee box. EC ethics committee. See also Ethics Committee box. EC European Commission (in documents older than the mid-1980s, EC may mean European Community) ECG electrocardiogram ECG European CDISC Group ECJ European Court of Justice ECOG Eastern Cooperative Oncology Group (U.S.) ECPHIN European Community Pharmaceutical Products Information Network eCRF electronic case report form EDC electronic data capture/collection EDI electronic data interchange EEC European Economic Community, now EU; some regulatory documents still have EEC document numbers EFGCP European Forum for Good Clinical Practice EFPIA European Federation of Pharmaceutical Industries and Associations EFTA European Free Trade Association EIR Establishment Inspection Report (FDA) ELA Establishment License Application (FDA) EMEA European Agency for the Evaluation of Medicinal Products EMS electronic mail service EMWA European Medical Writers Association EORTC European Organization for the Research and Treatment of Cancer EP European Parliament EPAR European Public Assessment Report EPO European Patent Office EPRG European Pharmacovigilance Research Group ER Essential Requirements (EMEA) ESRA European Society of Regulatory Affairs ESTRI Electronic Standards for the Transfor of Regulatory Information (ICH) EU European Union EUDRA European Union Drug Regulatory Authorities EUDRACT European Union clinical trials database EWG expert working group

F

FAQ frequently asked questions Farmindustria The Association of Italian Pharmaceutical Manufacturers FD&C Act Food, Drug, and Cosmetic Act (U.S.) FDA Food and Drug Administration (U.S.) FDAMA FDA Modernization Act FDLI Food and Drug Law Institute FFPM Fellow of the Faculty of Pharmaceutical Medicine (UK) FRCP Fellow of the Royal College of Physicians, sometimes followed by a place name—for example, FRCP (Edin.)—that indicates a university medical school FTC Federal Trade Commission (U.S.) FTP File Transfer Protocol FWA Federal-wide assurance

G

GAO General Accounting Office (U.S. government) GBP good business practice Gbps gigabits or billions of bits per second (data transmission) GCP good clinical practice GCRP good clinical research practice GLP good laboratory practice GMP good manufacturing practice GP general practitioner; general practice (UK) GPMS good postmarketing surveillance practice (Japan) GRAS generally regarded as safe (foods) GXP good [pharmaceutical] practice

H

HCFA Health Care Financing Administration; now renamed The Centers for Medicare & Medicaid Services. HEX human experimentation committee. See also Ethics Committee box. HHS Department of Health and Human Services (U.S., also called DHHS) HIMA Health Industry Manufacturers Association HIMSS Health Information and Management Systems Society HIPPA Health Insurance Portability and Accountability Act HL7 Health Level 7 (a not-forprofit ANSI-accredited standards developing organization (SDO) HPB Health Protection Branch, Laboratory Centre for Disease Control (Canada) HPLC high performance liquid chromatography HSRC human subjects review committee. See also Ethics Committee box. HTML Hypertext Markup Language HTTP Hypertext Transfer Protocol

I

I3C India CDISC Coordinating Committee IAB Industry Advisory Board (for CDISC) IB investigator’s brochure IC informed consent ICD9 International Classification of Diseases, 9th revision. See also MedDRA. ICG India CDISC Group ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICR Institute of Clinical Research (formerly ACRPI, Association for Clinical Research in the Pharmaceutical Industry, UK) ICSR individual case safety report ICTH International Committee on Thrombosis and Haemostases IEC independent ethics committee. See also Ethics Committee box. IEEE Institute of Electrical and Electronic Engineers, Inc. IFAPP International Federation of Associations of Pharmaceutical Physicians IFPMA International Federation of Pharmaceutical Manufacturers’ Associations IG Inspector General (HHS) IKS Interkantonale Kontrollstelle für Heilmittel (Switzerland) IMP investigational materials plan IND Investigational New Drug application (FDA). See also TIND IOM Institute of Medicine (National Academy of Science, U.S.) IPRO independent pharmaceutical research organization. See also CRO IRB institutional review board; independent review board. See also Ethics Committee box. IRD International Registration Document ISCB International Society for Clinical Biostatistics ISDN Integrated Services Digital Network ISO International Organization for Standardization ISP Internet service provider IT information technology ITU-T Telecommunication Standardization Sector of the International Telecommunications Union IVD in vitro diagnostics IVR interactive voice response (telephone technology) IVRS interactive voice response system

J

J3C Japan CDISC Coordinating Committee JCAHO Joint Commission on Accreditation of Healthcare Organizations JCG Japan CDISC Group JMA Japan Medical Association JPMA Japan Pharmaceutical Manufacturers Association Kbps kilobits or thousands of bits per second (data transmission)

L

LAB Laboratory Data Model (CDISC) LAN local area network LIF Swedish Pharmaceutical Industry Association LKP Leiter der klinischen Prüfung LOA letter of agreement LREC local research ethics committee (UK). See also Ethics Committee box.

M

MA marketing authorization MAA Marketing application (EU) Mbps millions of bits per second (data transmission) MCA Medicines Control Agency (UK) MDR Medical Device Reporting MedDRA Medical Dictionary for Regulatory Activities (new global standard medical terminology designed to supersede other terminologies used in the medical product development process, including COSTART, ICD9, and others) MEDLARS Medical Literature Analysis and Retrieval System MEFA Association of the Danish Pharmaceutical Industry MEP Member of the European Parliament MHLW Ministry of Health, Labor and Welfare (Japan) MIAME minimum information about a microarray experiment (standard for microarray data) MOH Ministry of Health (UK, Canada, others) MOPH Ministry of Public Health MOU Memorandum of Understanding (an MOU between FDA and a regulatory agency in another country allows mutual recognition of inspections) December 2003 actmagazine.com APPLIED CLINICAL TRIALS 29 MR medical representative (Japan) MRA medical research associate MREC multicentre research ethics committee(UK). See also Ethics Committee box. MRI magnetic resonance imaging MTD maximum tolerated dose MVP master validation plan

N

NABR National Association for Biomedical Research NAF Notice of Adverse Findings (FDA postaudit letter) NAI No Action Indicated (most favorable FDA postinspection classification) NAS new active substance (UK) NAS–NRC National Academy of Sciences–National Research Council (U.S.) NBAC National Bioethics Advisory Commission (U.S.) NCCAM National Center for Complementary and Alternative Medicine, formerly Office of Alternative Medicine (NIH) NCCTG North Central Cancer Treatment Group (U.S.) NCDM Nordic Clinical Data Management (Association) NCE new chemical entity NCHGR National Center for Human Genome Research (NIH) NCHS National Center for Health Statistics (in CDC) NCI National Cancer Institute (NIH) NCPDP National Council for Prescription Drug Programs NCPIE National Council on Patient Information and Education (Washington, DC) NCR no carbon [paper] required NCRR National Center for Research Resources (NIH) NCVIA National Childhood Vaccine Injury Act (1986) NDA New Drug Application (FDA) NDS New Drug Submission (Canada’s new drug application) NEFARMA Dutch Association of the Innovative Pharmaceutical Industry NEI National Eye Institute (NIH) NGO nongovernmental organization NHI National Health Insurance (Japan) NHLBI National Heart, Lung, and Blood Institute (NIH) NHS National Health Service (UK) NIA National Institute on Aging (NIH) NIAAA National Institute on Alcohol Abuse and Alcoholism (NIH) NIAID National Institute of Allergies and Infectious Diseases (NIH) NIAMS National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH) NICHD National Institute of Child Health and Human Development (NIH) NIDA National Institute on Drug Abuse (NIH) NIDCD National Institute on Deafness and Other Communication Disorders (NIH) NIDDK National Institute of Diabetes and Digestive and Kidney Diseases (NIH) NIDR National Institute of Dental Research (NIH) NIEHS National Institute of Environmental Health Sciences (NIH) NIGMS National Institute of General Medical Sciences (NIH) NIH National Institutes of Health (DHHS) NIMH National Institute of Mental Health (NIH) NINDS National Institute of Neurological Disorders & Stroke (NIH) NINR National Institute of Nursing Research (NIH) NIRB noninstitutional review board. See also Ethics Committee box. NLM National Library of Medicine (NIH) NME new molecular entity NOEL No observable effect level [dose of an experimental drug given pre-clinically, that does not produce an observable toxicity] NRB noninstitutional review board, also known as an independent review board. See also Ethics Committee box. NSCLC non-small cell lung carcinoma NTP National Toxicology Program

O

OAI Official action indicated (serious FDA post-inspection classification) OAM See NCCAM ODAC Oncologic Drugs Advisory Committee (U.S.) ODE Office of Drug Evaluation (CDER now has five such offices: ODE I, II, III, IV, and V) ODM Operational Data Model [CDISC] OGD Office of Generic Drugs (CDER, formerly DGB) OGE Office of Government Ethics (formerly part of Office of Personnel Management, separate executive branch in 1989) OHRP Office for Human Research Protections OIG Office of the Inspector General OJC Office Journal of the European Union–C Series (Information) OJEC Official Journal of the European Communities OJL Office Journal of the European Union–L Series (Legislation) OMB Office of Management and Budget (U.S.) OPRR Office for Protection from Research Risks (predecessor to OHRP) OSHA Occupational Safety Health Administration (U.S.) OTA Office of Technology Assessment (U.S.; abolished by Congress, Fall 1995) OTC over-the-counter (refers to nonprescription drugs)

P

PAB Pharmaceutical Affairs Bureau (Japan) PAHO Pan American Health Organization 30 APPLIED CLINICAL TRIALS actmagazine.com December 2003 PCC Poison Control Center PCP Pneumocystis carinii pneumonia PD pharmacodynamics PDA personal digital assistant (Palm Pilot, for example) PDF Portable Document Format PDQ Physicians’ Data Query (NCI-sponsored cancer trial registry) PDR Physicians’ Desk Reference PDUFA Prescription Drug User Fee Act (1992, U.S.) PEM prescription event monitoring PERI Pharmaceutical Education & Research Institute (notfor- profit division of PhRMA) PFT pulmonary function tests PhRMA Pharmaceutical Research and Manufacturers of America (formerly PMA) PHS Public Health Service (U.S.) PI principal investigator PK pharmacokinetics PKI public key infrastructure PLA Product License Application (FDA) PMA Pre-Market Approval application (FDA) PMS postmarketing surveillance PPI patient package insert PPO preferred provider organization; policy and procedure order PR partial response; pulse rate PRIM&R Public Responsibility in Medicine and Research (Boston, MA) PROG peer-review oversight group (NIH) PSUR periodic safety update report PTC Points to Consider

Q

QA quality assurance QAU quality assurance unit QC quality control QL quality of life QOL quality of life

R

R&D research and development RADAR Risk Assessment of Drugs—Analysis and Response RAPS Regulatory Affairs Professionals Society RCRIM Regulated Clinical Research and Information Management (HL7) RCT randomized clinical trial RDE remote data entry RDRC Radioactive Drug Research Committee REB research ethics board (Canada) RIM Reference Information Model (HL7) RKI Robert-Koch-Institut, Bundesinstitut für Infektionskrankheiten und nich-übertragbare Krankheiten (Federal Institute for Infectious and Non-communicable Diseases, Germany) RL regulatory letter (FDA postaudit letter)

S

SAE serious adverse event SAS Statistical Analysis System (commonly used statistical analysis package) SATCM State Administration of Traditional Chinese Medicine (China) SBA summary basis of approval SC study coordinator. See also CRC, CCRC, SSC SCDM Society for Clinical Data Management (US) SCT Society for Clinical Trials SD standard deviation SDA State Drug Administration (China) SDM Submission Data Model (CDISC) SDO standards development organization SDS Submission Domain Standards (CDISC) SDS submissions data standard SE standard error (statistics) SEA Single European Act of 1987 SEER Surveillance, Epidemiology, and End Results program of the the National Cancer Institute that collects and publishes cancer incidence and survival data. SGML Standard Generalized Markup Language SIAC Special Interest Area Community (DIA) SIG Special Interest Group (HL7) SLA service level agreement SMART Submission Management and Review Tracking (FDA) SME significant medical event SMO site management organization SmPC Summary of Product Characteristics SNDA Supplemental New Drug Application SNIP Syndicat National de l’Industrie Pharmaceutique (France) SNOMED Systematized Nomenclature of Medicine (a dictionary) SOCRA Society of Clinical Research Associates SOP standard operating procedure SPAC State Pharmaceutical Administration of China SPM Society of Pharmaceutical Medicine (UK) SQA Society of Quality Assurance SQAP systems quality assurance plan SSC study site coordinator. See also CRC, CCRC, SC SSCT Swedish Society for Clinical Trials SSFA Società di Scienze Farmacologiche Applicate (Italy) STF study tagging file STT short term tests SC study coordinator. See clinical research coordinator. SUA serious unexpected adverse event SUD sudden unexpected death SWOG Southwest Oncology Group (U.S.)

T

TC Technical Committee (HL7) TCC Technical Coordinating Committee (CDISC) TCP/IP Transmission Control Protocol/Internet Protocol TESS treatment emergent signs and symptoms TIND Treatment IND. See also IND TK toxicokinetics Tmax the time after dosing when Cmax occurs TMO trial management organization

U

URL uniform resource locator (address of a Web site) USC United States Code (book of laws) USDA Department of Agriculture (U.S.) USP United States Pharmacopeia

V

VA Veterans Administration (officially, United States Department of Veterans Affairs) VAERS Vaccine Adverse Event Reporting System VAI Voluntary Action Indicated (FDA postaudit inspection classification) VGDS Voluntary Genomic Data Submission VPN virtual private network

W

WAN wide area network WHO World Health Organization WHOART World Health Organization Adverse Reaction Terminology WL Warning Letter (most serious FDA postaudit letter, demands immediate action within 15 days) WRAIR Walter Reed Army Institute of Research (DoD) WTO World Trade Organization www World Wide Web

X

XML Extensible Markup Language

Clinical Trial Acronyms

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4S Scandinavian simvastatin survival study;
6C trial cooperative colorectal cancer combination chemotherapy clinical;
AAASPS African-American antiplatelet stroke prevention study;
AASK African-American study of kidney disease and hypertension
ABC study Association of Black Cardiologists study of hypertension;
ABCD alternans before cardioverter-defibrillator
appropriate blood pressure control in diabetes
AbESTT abciximab [ReoPro™] in emergent stroke treatment trial
ACADEMIC azithromycin in coronary artery disease: elimination of myocardial infection with chlamydia
ACAS asymptomatic carotid atherosclerosis study;
ACCENT A Crohn's disease clinical trial evaluating infliximab in a new long-term treatment regimen
ACCESS acute candesartan cilexetil evaluation in stroke survivors
a case control etiological study of sarcoidosis
ACCORD action to control cardiovascular risk in diabetes
ACES Avelox™ clinical experience study
azithromycin and coronary events study
ACME angioplasty compared to medicine
ACIP asymptomatic cardiac ischemia pilot study
ACRE appropriateness of coronary revascularization
ACST asymptomatic carotid surgery trial
ACT angioplasty compliance trial
attacking claudication with ticlopidine
ACTION a clinical trial in overt nephropathy;
actinomycin eluting stent improves outcomes by reducing neointimal hyperplasia
a coronary disease trial investigating outcome with nifedipine GITS
ACUTE analysis of coronary ultrasound thrombolysis endpoints in acute myocardial infarction; Angiosonics
assessment of cardioversion utilizing transesophageal echocardiography;
ADAM Amsterdam duration of antiretroviral medication study
aneurysm detection and management study
ADAPT Alzheimer's disease anti-inflammatory prevention trial;
ADCS Alzheimer's disease cooperative study
ADEMEX adequacy of peritoneal dialysis in Mexico; sponsor: Baxter Healthcare Corporation
ADEPT advanced elements of pacing trial; sponsor: Medtronic
ADMIRAL abciximab before direct angioplasty and stenting in myocardial infarction regarding acute and long-term followup
ADMIT arterial disease multiple intervention trial
ADONIS aspirin dose optimized in noncardioembolic ischemic stroke
ADOPT a diabetes outcome progression trial;
ADOPT-A atrial dynamic overdrive pacing trial-A
ADVANCE a dosing evaluation of a vasopressin antagonist in CHF patients undergoing exercise
AEGIS alternative graft investigational study;
AFCAPS Air Force coronary atherosclerosis prevention study
AFFIRM atrial fibrilation followup: investigation of rhythm management
AFIB atrial fibrillation investigation with bidisomide
AGENT angiogenic gene therapy
AGIS advanced glaucoma intervention study
A-HeFT African-American heart failure trial;
AIR aerosolized iloprost randomized placebo-controlled study; sponsor: Schering AG
AIST-ASH acute ischemic stroke trial: oral aspirin vs intravenous heparin on stroke progression
ALERT adjunctive Lamictal® in epilepsy and response to treatment
assessment of Lescol® in renal transplantation
ALIVE adenosine lidocaine infarct zone viability enhancement
amiodarone versus lidocaine in prehospital ventricular fibrillation evaluation; sponsor: Wyeth Pharmaceuticals
azimilide postinfarct survival evaluation;
ALLHAT antihypertensive and lipid-lowering treatment to prevent heart attack trial;
ALLIANCE aggressive lipid lowering to alleviate new cardiovascular endpoints
ALTS ASCUS/LSIL triage study
[ASCUS - atypical squamous cells of undetermined significance; LSIL - low-grade squamous intraepithelial lesion]
AMAZE a multicenter trial using Atacand®-Zestril®* versus Zestril to evaluate the effects on lowering blood pressure [*Atacand as add-on therapy with Zestril]
AMIGO AC2993: diabetes management for improving glucose outcomes; sponsor: Amylin Pharmaceuticals, Inc.
AMISTAD acute myocardial infarction study of adenosine;
APASS antiphospholipid antibody stroke study
APC adenoma prevention with celecoxib;
APOCARD Apomate™ imaging in cardiac transplant patients
APRES angiotensin-converting enzyme inhibition post revascularization study
ARCH amiodarone reduction in coronary heart
ARCHeR Acculink™ for revascularization of carotids in high-risk patients
AREDS age-related eye disease study
ARIC atherosclerosis risk in communities
ARMS APSAC reocclusion multicenter study
ARREST AngioRad™ radiation for restenosis;
ARTISTIC AngioRad™ radiation therapy for in-stent restenosis intracoronary;
ASAP azimilide supraventricular arrhythmia program;
ASCENT ACS stent clinical equivalence in de novo lesions trial
ASCOT Anglo-Scandinavian cardiac outcome trial
ASPECT anticoagulants in the secondary prevention of events in coronary thrombosis;
ASPEN atorvastatin [Lipitor™] study for the prevention of endpoints for patients with NIDDM
ASSENT assessment of the safety and efficacy of a new thrombolytic [TNKase™];
ASTIS autologous stem cell transplantation international scleroderma trial
ASTRID atrial sensing trial to prevent inappropriate detections
ASTRONAUT acid suppression trial: ranitidine [Zantac®] versus omeprazole [Prilosec®] for NSAID-associated ulcer treatment
ATAC Arimidex (anastrozole), tamoxifen and combination therapy
Arimidex (anastrozole) and tamoxifen alone or in combination
ATBAT anticoagulant therapy with bivalirudin [Angiomax™] to assist in PCI 1st inning trial (PCI in HIT/HITTS)
ATICH antifibrinolytic therapy in acute intracerebral hemorrhage
ATLAS Acolysis during treatment of lesions affecting saphenous vein bypass grafts; Angiosonics' Acolysis System™
assessment of treatment with lisinopril and survival;
ATLANTIC angina treatments – lasers and normal therapies in comparison
ATLANTIS alteplase thrombolysis for acute noninterventional therapy in ischemic stroke
AT LAST antiretroviral trial looking at sex and treatment
AtoZ Aggrastat® to Zocor® study; sponsor: Merck
ATRIA anticoagulation and risk factors in atrial fibrillation
ATS amblyopia treatment study
ATTRACT anti-TNF trial in rheumatoid arthritis with cA2 treatment;
anti-TNF trial in rheumatoid arthritis with concomitant therapy
AVASIS aspirin versus anticoagulants in symptomatic intracranial stenosis
AVERT artificial valve endocarditis reduction trial
atorvastatin versus revascularization treatments
AVID antiarrhythmics versus implantable defibrillators
AWESOME angina with extremely serious operative mortality evaluation
AZACS azithromycin in acute coronary syndromes
BARI
BARI 2D
bypass angioplasty revascularization investigation
bypass angioplasty revascularization investigation 2 diabetes;
BARS Beaumont alcohol restenosis study
BASC blood pressure in acute stroke collaboration
BATMAN BiodivYsio® 'bat'imastat SV stent versus balloon angioplasty for the reduction of restenosis in small coronary arteries;
BCPT breast cancer prevention trial
BEAT bucindolol evaluation in acute myocardial infarction trial;
BECAIT bezafibrate coronary atherosclerosis intervention trial
BELLES beyond endorsed lipid lowering with EBCT scannings
BENEFIT Betaferon® [Betaseron® in U.S.] in newly emerging MS for initial treatment; information
BENESTENT Belgium Netherlands stent
BERT beta energy restenosis trial;
BESMART beStent™ in small arteries
BEST beta-blocker evaluation of survival trial;
BEST-ICD beta-blocker evaluation of survival trial plus ICD
BETTER beta radiation trial to eliminate restenosis;
BHACAS beating heart against cardioplegic arrest studies
BIP bezafibrate infarction prevention
BLIND-DATE blinded withdrawal of deprenyl in the DATATOP extension trial
BLOSS beta blocker length of stay study
BPAV balloon prophylaxis of aneurysmal vasospasm
BRAINS Bayer randomized acute ischemia neuroprotectant study
biochemical research and information study
BRAVO beta radiation for treatment of arteriovenous graft outflow; sponsor: Novoste Corporation [Corona™ system]
blockade of the GP IIb/IIIa receptor to avoid vascular occlusion;
BREATHE-1 bosentan [Tracleer™]: randomized trial of endothelin receptor antagonist therapy for pulmonary hypertension
BRILLIANT batimastat (BB-94) antirestenosis trial utilizing the BiodivYsio® local drug delivery PC stent;
BRITE
BRITE-SVG
beta radiation to reduce in-stent restenosis;
beta radiation to reduce in-stent restenosis for saphenous vein bypass grafts
CABERNET carotid artery revascularization using the Boston Scientific EPI FilterWire EX and the EndoTex NexStent
CACHET comparison of abciximab complications with Hirulog® [Angiomax™ as of 1999] ischemic events trial
CADILLAC controlled abciximab [ReoPro™] and device investigation to lower late angioplasty complications
CAESAR Canada, Australia, Europe, South Africa AIDS study;
CALM candesartan and lisinopril microalbuminuria study
CALM-PD comparison of the agonist pramipexole vs. levodopa on motor complications in Parkinson disease
CALYPSO cylexin as an adjunct to lytic therapy to prevent superoxide reflow injury
CAMELOT comparison of amlodipine versus enalapril [Lipitor®] to limit occurrences of thrombosis
CAMEO cerebral aneurysm multicenter European Onyx™
CANDLE candesartan versus losartan efficacy comparison;
CAPARES coronary angioplasty amlodipine restenosis study
CAPRICORN carvedilol post infarction survival control in left ventricular dysfunction
CAPRIE clopidogrel versus aspirin in patients at risk of ischemic events;
CAPT complications of AMD [age-related macular degeneration] prevention trial
CAPTEN captopril after thrombolysis trial;
CAPTIM comparison of angioplasty and prehospital thrombolysis in acute myocardial infarction
CAPTIN captopril before reperfusion in acute myocardial infarction
captopril plus tissue plasminogen activator following acute myocardial infarction
CAPTURE c7E3 antiplatelet therapy in unstable refractory angina
CARDIA coronary artery risk development in young adults
CARDS collaborative atorvastatin [Lipitor™]and diabetes study
CARE calcium antagonist in reperfusion;
cholesterol and recurrent events;
carvedilol atherectomy restenosis;
CARE-HD coenzyme Q10 and remacemide: evaluation in Huntington disease
CARE-HF cardiac resynchronization - heart failure; European complement to U.S./Canada MIRACLE study
CARISA combination assessment of ranolazine in stable angina;
CARMEN carvedilol ACE inhibitors remodelling mild heart failure evaluation
CART Canadian antioxidant restenosis trial
CASES Canadian activase for stroke effectiveness study
CASH cardiac arrest study-Hamburg
CAST cardiac arrhythmia suppression trial;
CASTLE candesartan amlodipine study of tolerability and efficacy
CAT Chinese ACE inhibitor in acute myocardial infarction trial
cardiomyopathy trial
CATAPULT cisplatin and tirapazamine in subjects with advanced previously untreated non–small cell lung tumors
CATIE clinical antipsychotic trials of intervention effectiveness; see trial information
CATS Canadian American ticlopidine study
captopril and thrombolysis study
CAVATAS carotid and vertebral artery transluminal angioplasty study
CBT-CD cognitive behavior therapy for the chronic depressions;
CEDARS comprehensive evaluation of defibrillators and resuscitative shock
CEOS congenital esotropia observational study
CHAMP children's HIV and AIDS model program
combination chemotherapy and mortality prevention
CHAMPIONS controlled high-risk subjects Avonex™ MS prevention in ongoing neurologic surveillance
CHAMPS controlled high-risk subjects Avonex™ MS prevention study
CHARM candesartan cilexitil [Atacand™] in heart failure assessment of reduction mortality and morbidity
CHEESE comparative trial of HIV-infected patients evaluating efficacy and safety of saquinavir-enhanced oral formulation and indinavir given as part of a triple drug therapy;
CHF-STAT congestive heart failure survival trial of antiarrhythmic therapy
CHRISTMAS carvedilol hibernation reversible ischemia trial; marker of success
CHS cardiovascular health study
Charleston heart study
community health study
Congenital Heart Surgeons Society study
coronary heart study
CIBIS cardiac insufficiency bisoprolol study
CIDS Canadian implantable defibrillator study; sponsor: Medtronic
CIGTS collaborative initial glaucoma treatment study
CLASS celecoxib [Celebrex®] long-term arthritis safety study
clomethiazole acute stroke study
CLASSICS clopidogrel [Plavix™] aspirin stent international cooperative study
CLASS-IHT clomethiazole acute stroke study in ischemic, hemorrhagic, and tPA treated stroke
CLEERE collaborative longitudinal evaluation of ethnicity and refractive error
COAST heparin-coated stents in small coronary arteries
COCAD cognitive outcomes in coronary artery disease
COLA carvedilol open label assessment
COMBINE combining medications and behavorial interventions;
COMET carvedilol or metoprolol European trial
COMMA compliment inhibition in myocardial infarction treated with percutaneous transluminal coronary angioplasty [evaluation of IV dosing regimens of h5G1.1-scFv]; sponsors: Procter & Gamble and Alexion Pharmaceuticals
COMPANION comparison of medical therapy, pacing and defibrillation in chronic heart failure; Guidant Corporation
COMPLY compliment inhibition in myocardial infarction treated with thrombolytics [evaluation of IV dosing regimens of h5G1.1-scFv]; sponsors: Procter & Gamble Pharmaceuticals and Alexion Pharmaceuticals
COMS collaborative ocular melanoma study
CONVINCE controlled onset verapamil investigation of cardiovascular endpoints
COOL cardiovascular thrombolytic to open occluded lines [t-PA]
COOL AID cooling for acute ischemic brain damage;
COOL MI cooling as an adjunctive therapy to percutaneous intervention in patients with acute myocardial infarction;
COPERNICUS carvedilol [Coreg®] prospective randomized cumulative survival
COPPA clinical outcomes from the prevention of postoperative arrhythmia
CORE continuing outcomes relevant to Evista™
COSS carotid occlusion surgery study
COURAGE clinical outcomes utilizing revascularization and aggressive drug evaluation;
COURT a randomized trial of contrast media utilization in high risk PTCA
CRASH corticosteroid randomization after significant head injury
CREDO clopidogrel [Plavix™] for reduction of events during observation
CREST carotid revascularization endarterectomy vs stenting trial
CRUISE can routine ultrasound influence stent expansion
CURE clopidogrel in unstable angina to prevent recurrent ischemic events
DAIS diabetes atherosclerosis intervention study
DAISY diabetes autoimmunity study in the young
DATATOP deprenyl and tocopherol antioxidative therapy of parkinsonism
DAVID dual-chamber and VVI implantable defibrillator; see
DEBATE Doppler endpoints balloon angioplasty trial Europe;
DECOPI la desobstruction coronaire en post-infarctus
DEFINITE defibrillators in nonischemic cardiomyopathy treatment evaluation
DEFUSE diffusion-weighted imaging evaluation for understanding stroke evaluation;
DESTINI-CFR Doppler endpoints stenting international investigation - coronary flow reserve;
DIADS depression in Alzheimer disease study
DIAGNOSIS diffusion-weighted imaging assessment of the genuine need for other studies in ischemic stroke
DIAMOND distensibility improvement with ALT-711 remodeling in diastolic heart failure; sponsor: Alteon Inc.
DIAMOND CHF Danish investigators of arrhythmia and mortality on dofetilde congestive heart failure;
DIGAMI diabetes mellitus insulin-glucose infusion in acute myocardial infarction
DMIST digital mammographic imaging screening trial
DINAMIT defibrillation in acute myocardial infarction trial
DIRECT diabetic retinopathy candesartan trial; candesartan cilexetil (Atacand®)
DIRECTOR direct stenting study with Orbus R stent™; sponsor: Orbus Medical Technologies
DISC disability in strategies for care
DISTINCT BiodivYsio™ stent in controlled trial
DPT-1 diabetes prevention trial - type 1;
DREAM diabetes reduction approaches with ramipril and rosiglitazone medications
DYSBOT Dysport and Botox study;
EAGAR estrogen and graft atherosclerosis research trial
EARS European atherosclerosis research study
ECCO 2000 effects of citicoline (CerAxon™) on clinical outcome - 2000 mg;
EDGE™ evaluation of daptomycin [Cidecin™] in gram-positive entities
EDGECAP evaluation of daptomycin [Cidecin™] in gram-positive entities in the treatment of community-acquired pneumonia
EDGESST evaluation of daptomycin [Cidecin™] in gram-positive entities in the treatment of complicated skin and soft tissue infections
EDGEUTI evaluation of daptomycin [Cidecin™] in gram-positive entities in the treatment of complicated urinary tract infection
ED-IMPACT emergency department impedance cardiography-aided assessment changes therapy; sponsor: CardioDynamics International
EFICAT ejection fraction in cardiac transplant patients
EGASIS early GABA-ergic activation sin troke
ELECT evaluating enoxaparin [Lovenox®] clotting times; see
ELITE evaluation of losartan in the elderly
ELLDOPA earlier versus later levodopa in Parkinson disease
ENABLE endothelin antagonist bosentan for lowering cardiac events in heart failure
ENCORE evaluation of nifedipine and cerivastatin on the recovery of endothelial function; web site
ENRICHD enhancing recovery in coronary heart disease
ENTIRE enoxaparin and TNK-tPA with or without GP IIb/IIIa inhibitor as reperfusion strategy in ST elevation MI [TIMI-23];
EPHESUS eplerenone neurohormonal efficacy and survival study;
eplerenone post-AMI heart failure efficacy and survival study
EPIC evaluation of c7E3 for prevention of ischemic complications
EPILOG evaluation in PTCA to improve long-term outcome with abciximab GP IIb/IIIa blockade;
EPISTENT evaluation of platelet IIb/IIIa inhibitor for stenting trial
ERA early rheumatoid arthritis (RA) study
enoxaparin restenosis after angioplasty study
estrogen replacement and atherosclerosis study
ERASE emergency room assessment of sestamibi for evaluation of chest pain
ERGO etomoxir for the recovery of glucose oxidation
ER-TIMI early Retavase™ - thrombolysis in myocardial infarction
ESCAPE evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness
ESPRIT enhanced suppression of the platelet IIb/IIIa receptor with Integrilin™ therapy
European study of the prevention of reocclusion after initial thrombolysis
evaluation of subcutaneous proleukin in a randomized international trial
ESPS2 European stroke prevention study 2
ESSENCE efficacy and safety of subcutaneous enoxaparin in non–Q-wave coronary events;
ESSENTIAL the studies of oral enoximone therapy in advanced heart failure; sponsor: Myogen, Inc.
ETHECC evaluation of Thymitaq™ in hepatocellular carcinoma; sponsor: Eximas Pharmaceutical Corporation
ETROP early treatment of retinopathy of prematurity
Euro-SPAH European-sonotherapy prevention of arterial hyperplasia; sponsor: PharmaSonics, Inc.
EVIDENCE evidence for interferon dose-effect: European-North American comparative efficacy study [Rebif® v. Avonex™ in relapsing-remitting multiple sclerosis (RRMS)]
EVIDENT endovascular investigation determining the safety of a new tacrolimus-eluting stent graft; sponsor: JOMED N.V.
EXCITE evaluation of oral xemilofiban in controlling thrombotic events;
EXCITe extremity constraint-induced therapy
EXCLAIM extended clinical prophylaxis in acutely ill medical patients [Lovenox™ (enoxaparin) postmarketing (phase IV) trial]; sponsor: Aventis
FACET fosinopril versus amlodipine cardiovascular events randomized trial
FAME fluvastatin [Lescol®] assessment of morbi-mortality in the elderly
FASTER fibrinolytic and Aggrastat® ST elevation resolution;
first abarelix depot study for treating endometriosis rapidly
first and second trimester evaluation of risk; see study information
FAST-MAG field administration of stroke therapy - magnesium
FIELD fenofibrate [TriCor®] intervention and event lowering in diabetes
FIRST Flolan (dobutamine) international randomized survival trial
first trimester integrated risk screening for trisomy [information]
FLARE fluvastatin [Lescol®] angiographic restenosis
FOOD feed or ordinary diet
FOSIT Fosamax® international trial
FRAXIS / FRAX.I.S. Fraxiparine® in ischemic syndromes
FRIC Fragmin® in unstable coronary artery disease
FRISC fast revascularization during instability in coronary artery disease
Fragmin® during instability in coronary artery disease
FROSTY Freezor™ trial of supraventricular tachycardia
FUSION fractional flow reserve and ultrasound indices for objective narrowing assessment
GART study genotypic antiretroviral resistance testing
GEMS 'Ginkgo biloba 'evaluation memory study
GISEN gruppo Italiano di studi epidemiologici in nefrologia
GUSTO global utilization of streptokinase and tPA for occluded arteries;
GUSTO-SPEED global utilization of streptokinase and tPA for occluded arteries–strategies for patency enhancement in the emergency department
HALT-C hepatitis C antiviral long-term treatment to prevent cirrhosis;
HANDLS health aging in nationally diverse longitudinal samples
HARDBALL heart allograft rejection: detection with breath alkanes in low levels
HeADDFIRST hemicraniectomy and durotomy for deterioration from infarction relating swelling trial
HEART healing and early afterload reducing therapy
HEAT 2 hypertension endothelin antagonist treatment
HEME hemorrhage early MRI evaluation
HERO Hirulog® early reperfusion/occlusion trial
HERS heart and estrogen/progestin replacement study
HIV epidemiology research study
HESTIA home evaluation of stroke induced aid
HIPS heparin infusion prior to stenting;
HIT HDL-cholesterol intervention trial
hirudin for the improvement of thrombolysis
HOPE heart outcomes prevention evaluation;
HOPE-TOO heart outcomes prevention evaluation - the ongoing outcomes
HORIZON health outcomes and reduced incidence with zoledronic once yearly
HOT hypertension optimum treatment
HPS heart protection study
HRS health and retirement study
HYVET hypertension in the very elderly trial
ICE-IT intravascular cooling adjunctive to primary coronary intervention
ICSS international carotid stenting study (CAVATAS-2)
IDEAL incremental decrease in endpoints through aggressive lipid lowering
Iressa® dose evaluation in advanced lung cancer
IDNT irbesartan [Avapro®] in diabetic nephropathy trial
IHAST intraoperative hypothermia for aneurysm surgery trial
IMAGES intravenous magnesium efficacy in stroke
IMAGINE ischemic management with Accupril™ post bypass graft via inhibition of converting enzyme
IMPACT Integrilin™ to manage platelet aggregation to prevent coronary thrombosis
international mexiletine or placebo antiarrhythmic coronary trial;
international multiple sclerosis secondary progressive Avonex™ controlled trial
IMPRESS inhibition of metalloprotease by BMS-186716 in a randomized exercise and symptoms study;
IMS interventional management of stroke study
INCOMIN independent comparison of interferon [Betaseron® v. Avonex™ in relapsing-remitting multiple sclerosis (RRMS)]
InDDEx investigation into delay to diagnosis of Alzheimer disease with Exelon™
INHIBIT intimal hyperplasia inhibition with beta in-stent trial; Guidant Corporation
INSIGHT international nifedipine once-daily study – intervention as a goal in hypertension treatment; web site
INTACT Iressa® non–small cell lung cancer trial assessing combination treatment
INTEGRITI Integrilin® and tenecteplase [TNKase™] in acute myocardial infarction;
InTIME intravenous nPA for treatment of infarcting myocardium early;
INTrEPID investigation of non–transplant-eligible patients who are inotrope dependent; see
INTRO-AMI Integrilin® and reduced dose of thrombolytic in acute myocardial infarction
IONA impact of nicorandil in angina
IONDT ischemic optic neuropathy decompression trial
IRAS insulin resistance atherosclerosis study
IRMA 2 irbesartan [Avapro®] microalbuminuria type 2
IRIS Isostent for restenosis intervention study
ISAAC international study of asthma and allergies in childhood
ISAR intracoronary stenting and antithrombotic regimen
ISAR-STEREO intracoronary stenting and angiographic results - strut thickness effect on restenosis outcome
ISAT international subarachnoid aneurysm trial
ISTICH international surgical trial in intracerebral hemorrhage
ITT intraventricular thrombolysis trial
IVAT intermediate sized vessel atherectomy trial
L-CAD lipid-coronary artery disease [pravastatin]; sponsor, Bristol-Myers Squibb
LACI laser angioplasty for critical ischemia;
LAMP locally advanced multimodality protocol; [1]
LARS laser angioplasty in restenosed stents
LaSRS late steroid rescue study
LATE late assessment of thrombolytic efficacy;
LEADER lower extremity arterial disease event reduction
LIDO levosimendan [Simdax™] infusion versus dobutamine in low output heart failure
LIDS lumbar invertebrae disk study [device trial]
LIFE losartan intervention for endpoint reduction in hypertension
LIMB ultrasound lysing in lower extremities to minimize blood clots; Angiosonics
LIMIT long lesion intracoronary radiation to minimize intimal hyperplasia trial; sponsor: Guidant Corp. [Galileo™ intravascular radiotherapy system]
LIPID long-term intervention with pravastatin in ischemic disease;
LONG WRIST Washington radiation for in-stent restenosis trial for long lesions
Look AHEAD action for health in diabetes [Xenical; long-term study of effects of weight loss in type 2 diabetics]
L-TAP lipid treatment assessment project
LV3P-CHF left ventricular pacing in pacemaker patients with congestive heart failure (CHF); sponsored by St. Jude Medical
MADIT multicenter automatic defibrillator implantation trial
MAGIC magnesium in coronay arteries
MARISA monotherapy assessment of ranolazine in stable angina;
MARRVEL magnetic resonance radionuclide ventriculography and echocardiography in left ventricular function
MARVAL microalbuminuria reduction with valsartan [Diovan®]
MASH magnesium and acetylsalicylic acid in subarachnoid hemorrhage
MATCH management of atherothrombosis with clopidogrel [Plavix™] in high-risk patients with recent transient ischemic attack or ischemic stroke
MDC metoprolol in dilated cardiomyopathy
MDPIT multicenter diltiazem post infarction trial
MEDENOX prophylaxis in medical patients with enoxaparin [Lovenox®]
MERIT-HF metoprolol CR/XL (controlled release) randomized intervention trial in heart failure;
MIAMI Multi-Link® Duet™ coronary stent in acute myocardial infarction
MICRO-HOPE microalbuminuria, cardiovascular, and renal outcomes (HOPE [heart outcomes prevention evaluation] substudy)
MIRA minocycline in rheumatoid arthritis
MIRACL myocardial ischemia reduction with aggressive cholesterol lowering
MIRACLE multicenter InSync™ randomized clinical evaluation (North America)
MIRACLE ICD multicenter InSync™ randomized clinical evaluation implantable cardioverter defibrillator
MIRAGE multi-institutional research in Alzheimer genetic epidemiology
MMAIT malignant melanoma active immunotherapy trials; [Canvaxin™]
MMSS MyoVive™ marketing surveillance study;
MOBILE more patency with beta for in-stent restenosis in the lower extremity; sponsor: Novoste Corporation [Corona™ system]
MOCHA multicenter oral carvedilol [Coreg®] heart failure assessment
MONICA monitoring trends and determinants in cardiovascular disease
MORE multiple outcomes of raloxifene evaluation
MOST mode selection trial in sinus node dysfunction
MOXCON moxonidine congestive heart failure trial;
MRFIT multiple risk factor intervention trial
MR IMAGES magnetic resonance in intravenous magnesium efficacy in stroke
MSMI multicenter study of myocardial ischemia
MUST medication use studies;
multicenter stent study;
multicenter stents ticlopidine;
MUST EECP multicenter study of enhanced external counterpulsation [EECP®]
MUSTIC multisite stimulation in cardiomyopathy
MUSTT multicenter unstable tachycardia trial;
multicenter unsustained tachycardia trial;
NAFT North American Fragmin® trial
NASCET North American symptomatic carotid endarterectomy trial;
NAVIGATOR nateglinide and valsartan in impaired glucose tolerance outcomes research;
NETT national emphysema treatment trial
NETWORK Network of general practitioners and hospital physicians involved in the study of low versus high doses of enalapril in patients with heart failure trial
NICE Novacor® inflow conduit evaluation; sponsor: World Heart Corporation
NICE 3 national investigators collaborating on enoxaparin [Lovenox®]
NOCIS new onset Crohn's intervention study
OASIS / OASIS-2 organization to assess strategies for ischemic syndromes
OAT open artery trial
OBJECT overactive bladder: judging effective control and treatment [Ditropan XL v. Detrol]
OCBAS optimal coronary balloon angioplasty versus stent
OCTAVE omapatrilat [Vanlev™] cardiovascular treatment assessment versus enalapril
OHTS ocular hypertension treatment study
OMNIUM omeprazole [Prilosec®] versus misoprostol [Cytotec®] for NSAID-induced ulcer management
ONTARGET ongoing telmisartan [Micardis®] alone and in combination with ramipril [Altace®] global endpoint trial
OPERA omapatrilat [Vanlev™] in persons with enhanced risk of atherosclerotic events;
OPTIC optimal pharmacological therapy in implantable cardioverter defibrillator patients; sponsor: St. Jude Medical
OPTIMAAL optimal trial in myocardial infarction with the angiotensin II antagonist losartan
OPTIME-CHF outcomes of a prospective trial of intravenous milrinone for exacerbations of chronic heart failure
OPUS orbofiban in patients with unstable coronary syndromes
ORBIT oral glycoprotein IIb/IIIa receptor blockade to inhibit thrombosis;
OVERTURE omapatrilat versus enalapril randomized trial of utility in reducing events;
PAC-A-TACH pacing in atrial fibrillation and tachycardia
PACIFIC potential angina class improvement for intramyocardial channels
PACT Philadelphia Association of Clinical Trials study
plasminogen activator angioplasty compatibility trial
prehospital application of coronary thrombolysis
prourokinase in acute coronary thrombosis
PAMI primary angioplasty in acute myocardial infarction;
PARADIGM pramlintide for amylin replacement adjunct for diabetes in glycemic management;
PARAGON platelet IIb/IIIa antagonism for the reduction of acute coronary syndrome events in the global organization network
PARIS peripheral artery radiation investigational study [study of the Nucletron® Paris® leg artery radiation catheter]
PASS II piracetam acute stroke study II search help: piracetam
PATH-CHF pacing therapies for congestive heart failure
PAVE post AV node ablation evaluation; sponsored by St. Jude Medical
PCDD prevention of cardiovascular disease in diabetes
PCI-CURE clopidogrel [Plavix®] in unstable angina to prevent recurrent ischemic events in patients undergoing percutaneous coronary intervention; companion to CURE study
PCPT prostate cancer prevention trial; information
PDQUALIF Parkinson('s) disease quality of life
PEACE prevention of events with angiotensin converting enzyme [ACE] inhibitor therapy
PEECH™ prospective evaluation of EECP® in congestive heart failure; sponsor, Vasomedical, Inc.
PENTALYSE synthetic pentasaccharide as an adjunct to fibrinolysis in ST-elevation acute myocardial infarction
PENTUA pentasaccharide in unstable angina
PEPI postmenopausal estrogen/progestin interventions study
PETHEMA programa para el estudio y tratamiento de las hemopatías malignas
[program for the study and treatment of malignant hemopathies]
PHADE pneumatic HeartMate® assist as destination evaluation;
PHAROS pilot Huntington at risk observational study
PIE protease inhibitor experienced [study of Fortovase™ with Kaletra™]
PIVOT prostate cancer intervention versus observation trial
PLESS Proscar® long-term efficacy and safety study;
PLUS propentofylline long-term use study
POEM patency, outcomes and economics of MIDCAB;
POLAR pilot study of low-temperature angiogenic revascularization; sponsor: CryoCath Technologies, Inc.
POST posterior stroke trial
potassium-channel opening stroke trial
POWER PTH for osteoporotic women on estrogen replacement [ALX1-11, a recombinant parathyroid hormone (PTH) formulation]; sponsor: NPS Pharmaceuticals
PRAGUE primary angioplasty in patients transferred from general community hospitals to specialized PTCA units with or without emergency thrombolysis
PRAISE prospective randomized amlodipine survival evaluation
PRECEDENT prospective randomized ectopy evaluation on dobutamine or Natrecor® (nesiritide) therapy; Scios Inc.
PREDICT-HD neurobiologic predictors of Huntington disease onset
PREFER preference study of Gengraf™ compared to Neoral™ in stable solid organ transplant subjects
PREPARE prevent postmenopausal Alzheimer’s with replacement estrogens (a.k.a. Alzheimer('s) disease prevention trial)
PRESENT preliminary safety evaluation of nanoporous tacrolimus-eluting stents; sponsor: JOMED N.V.
PRESTO Parkinson('s) rasagiline: efficacy & safety in the treatment of "OFF"
prevention of restenosis with tranilast and its outcomes
PREVENT prevention of recurrent venous thromboembolism
program in ex vivo vein graft engineering via transfection
proliferation reduction with vascular energy trial; sponsor: Guidant Corp.
prospective randomized evaluation of the vascular effects of Norvasc® trial
PRIDE protection during saphenous vein graft intervention to prevent distal embolization);
PRIME pramipexole in minority persons with Parkinson('s) disease: efficacy
program for irbesartan mortality and morbidity evaluations [consists of two studies: IRMA 2 and IDNT]
PRIMO-CABG pexelizumab for reduction in infarction and mortality in coronary artery bypass graft surgery
PRINCE pravastatin inflammation/CRP evaluation
PRINCESS prevention of reinfarction with early treatment by cerivastatin study
PRISM-PLUS platelet receptor inhibition for ischemic syndrome management in patients limited to very unstable signs and symptoms;
PROACT prolyse in acute cerebral thromboembolism
PROACTION prospective randomized outcomes study of acutely decompensated congestive heart failure treated initially in outpatients with Natrecor®;
PROBE Primacor (milrinone lactate) for optimization of beta-blocker efficacy
PROBE evaluation prospective, randomized, open, blinded endpoint;
PROBIT promotion of breastfeeding intervention trial
PROGENI Parkinson('s) research: the organized genetics initiative
PROGRESS perindopril [Aceon®] protection against recurrent stroke study
PROMPT profiling Remicade onset with methotrexate in a prospective trial
PROSPER prospective study of pravastatin in the elderly at risk
PROTEKT prospective resistant organism tracking for the ketolide telithromycin [Ketek™]
PROVE IT pravastatin or atorvastatin evaluation and infection therapy;
PROWESS recombinant human activated protein C [Xigris™] worldwide evaluation in severe sepsis
PSYCLOPS psychosis and clozapine in Parkinson's disease
PTAMD prophylactic treatment of AMD [age-related macular degeneration]
PURSUIT platelet glycoprotein IIb/IIIa in unstable angina: receptor suppression using Integrilin™ therapy
QoLITY quality of life trial hypertension;
QUIET quinapril [Accupril™] ischemic event trial
RACECAR restenosis and clinical evaluation in coronary arteries; sponsor: Medtronic
RALES randomized Aldactone® (spironolactone) evaluation study for congestive heart failure;
RAPID radiation after PTA is done; sponsor: Radiance Medical Systems [RDX™ coronary radiation delivery catheter]
rapid-acting Parkinson('s) drug
RAPPORT ReoPro® and primary PTCA organization and ramdomized trial
RAVEL randomized study with the sirolimus-eluting Bx Velocity™ balloon-expandable stent [Cypher™]; sponsor: Cordis
REACH rehabilitation among women with coronary heart disease
research on endothelin antagonism in chronic heart failure;
REACT rapid early action for coronary treatment; University of Minnesota and JAMA 2000;283:3223-3229 [July 5, 2000]
ReALIZe research to assess the long-term impact of Zomaril™
RECIFE reduction of cholesterol in ischemia and function of the endothelium
REDHOT rapid emergency department heart failure outpatient trial
[Trial to evaluate clinical utility of the Triage® BNP test in assessing effectiveness of therapy in the management of CHF.]
REGRESS regression growth evaluation statin study
REIN ramipril efficacy in nephropathy
REMATCH randomized evaluation of mechanical assistance therapy as an alternative in congestive heart failure;
RENAAL reduction in endpoints in patients with non–insulin-dependent diabetes mellitus with the angiotensin II antagonist losartan
RENAISSANCE randomized Enbrel® North American strategy to study antagonism of cytokines
RESPECT risk evaluation and stroke prevention in the elderly - cerivastatin trial;
RESTOR R stent™ efficacy and safety trial Orbus; sponsor: Orbus Medical Technologies
RESTORE randomized efficacy study of tirofiban for outcomes and restenosis;
REVERSAL reversal of atherosclerosis with Lipitor™
REVERT reversal of ventricular remodeling with Toprol-XL®;
RHYTHM resynchronization for hemodynamic treatment for heart failure management; sponsor: St. Jude Medical [Epic™ HF ]
RID-HD riluzole dosing in Huntington disease
RITZ-2 randomized intravenous tezosentan
ROSTER rotational atherectomy versus balloon angioplasty for diffuse in-stent restenosis
RUTH raloxifene use for the heart;
SADHAT sertraline (Zoloft®) antidepressant heart attack trial
SADHART sertraline antidepressant heart attack randomized trial
SAFE safety after fifty evaluation
SAFER saphenous vein graft angioplasty free of emboli randomized trial; entry
SAFE-T sotalol and amiodarone atrial fibrillation effectiveness trial
SAGE study assessing goals in the elderly
SAPPHIRE systolic and pulse pressure hemodynamic improvement by restoring elasticity; sponsor: Alteon Inc. [ALT-711]
SARECCO stent or angioplasty after recanalization of chronic coronary occlusions
S.A.V.S. Synercid® as an alternative to vancomycin in staph[ylococcal infections] SAVS
SCD-HeFT or SCDHeFT sudden cardiac death/heart failure trial
SCRIP study of cardiovascular risk intervention by pharmacists
SCRIPPS Scripps coronary radiation to inhibit proliferation post stenting
SEAL simple and effective arterial closure study;
SEARCH study of effectiveness of additional reductions of cholesterol and homocysteine
SECURE study to evaluate carotid ultrasound changes in patients treated with ramipril [Altace®] and vitamin E
SELECT selenium and vitamin E cancer prevention trial; description
SELENA safety of estrogens in lupus erythematosus national assessment
SHARP subcutaneous heparin and angioplasty restenosis prevention
SHELTER stenting of high risk patients extracranial lesions trial with emboli removal;
SHEP systolic hypertension in the elderly program
SHIPS study of a home intervention post stroke
SHOCK should we emergently revascularize occluded coronaries for cardiogenic shock
SHOW study of health outcomes in weight loss
SICCO stenting in chronic coronary occlusion
SIESTA snooze-induced excitation of sympathetic triggered activity
SILCAAT study of interleukin-2 (IL-2) in people with low CD4+ T-cell counts on active anti-HIV therapy; Chiron Corporation
SILENT sonotherapy for in-lesion elimination of neointimal tissue; sponsor: PharmaSonics Inc.; also see
SILVER systolic hypertension interaction with left ventricular remodeling; sponsor: Alteon Inc. [ALT-711]
SIRIUS a multicenter randomized double-blind study of the sirolimus-coated Bx Velocity™ stent [referred to as Cypher™ sirolimus-eluting stent] in the treatment of patients with de novo coronary artery lesions; sponsor: Cordis search help: s/l "serious"
SIROCCO sirolimus-coated Cordis S.M.A.R.T™ nitinol self-expanding stent in the treatment of obstructive superficial femoral artery disease
SMART second manifestations of arterial disease
serum markers acute myocardial infarction and rapid treatment
strategies for the management of antiretroviral therapy
study of medicine versus angioplasty reperfusion trial
study of Microstent's ability to limit restenosis trial
study of monoclonal antibody radioimmunotherapy;
Synercid® microbiological assessment of resistance trends;
SMILE survival of myocardial infarction long-term evaluation
SNAP study of nitroglycerin and chest pain
SPAF stroke prevention in atrial fibrillation
SPEED strategies for patency enhancement in the emergency department
SPORT spine patient ooutcomes research trial
stent implantation post rotational atherectomy trial
SPORTIF-V stroke prevention using oral thrombin inhibition in atrial fibrillation - V [5th series of SPORTIF trials];
SOLVD studies of left ventricular dysfunction
SONIA stroke outcomes and neuroimaging of intracranial atherosclerosis
SONORA safety of Neoral outcomes in rheumatoid arthritis
S.O.N.O.R.A.SM study of new onset rheumatoid arthritis; sponsor: Knoll Pharmaceutical Company
SoS stent or surgery
SPARCL stroke prevention by aggressive reduction in cholesterol levels
SPICE study of protease inhibitor combination in Europe;
SPLASH sonotherapy prevention of late arterial in-stent hyperplasia; sponsor: PharmaSonics, Inc.; also see
SPS3 stroke prevention of small subcortical strokes
SSITT Swiss-Spanish intermittent trial
SSYLVIA stenting in symptomatic atherosclerotic lesions of vertebral and intracranial arteries
STAR study of tamoxifen and raloxifene;
STARS standard treatment with activase to reverse stroke
START saruplase and taprostene acute reocclusion trial
St. Thomas' atherosclerosis regression trial
study of thrombolytic therapy with additional response following taprostene
stent versus angioplasty restenosis trial
stent versus directional coronary atherectomy randomized trial
stents and radiation therapy;
selection of thymidine analog regimen therapy;
STAT stroke treatment with ancrod trial
Stent PAMI stent primary angioplasty for myocardial infarction
STEP-BD systematic treatment enhancement program for bipolar disorder; study description
STICH surgical treatment for intracerebral hemorrhage
STOP sonotherapy for the treatment of peripheral vascular disease; sponsor: PharmaSonics, Inc.
STOP-DUB surgical treatments outcomes project for dysfunctional uterine bleeding
STOP-Hypertension Swedish trial in old patients with hypertension;
STRATAS study to determine Rotablator® and transluminal angioplasty strategy
STRENGTH
STRENGTH II
statin response examined by genetic HAP™ markers; sponsor: Genaissance Pharmaceuticals
STRESS stent restenosis study
STRETCH symptom, tolerability, response to exercise trial of candesartan cilexetil [Atacand™] in heart failure
STRIDE sitaxsentan to relieve impaired exercise in pulmonary hypertension
SUDEP sudden unexpected death in epilepsy
SWEDIC Sweden diastolic carvedilol
SWIFT should we intervene following thrombolysis
SWING sound waves inhibit neointimal growth; sponsor: PharmaSonics Inc.; also see
SWISS siblings with ischemic stroke study
SWOG Southwest Oncology Group [an adult cancer clinical trials organization]; SWOG protocols by indication
SYMPHONY sibrafiban versus aspirin to yield maximum protection from ischemic heart events post-acute coronary syndromes;
SYNERGY superior yield of the new strategy of enoxaparin, revascularization, and glycoprotein IIb/IIIa inhibitors
TACT trial to assess chelation therapy [EDTA chelation therapy for coronary artery disease]; sponsor: National Institutes of Health (NIH)
TACTICS thrombolysis and counterpulsation to improve cardiogenic shock survival
treat angina with Aggrastat® and determine costs of therapy with invasive or conservative strategies [TIMI-18]
TAIST tinzaparin in acute ischemic stroke trial
TARGET do tirofiban [Aggrastat®] and ReoPro give similar efficacy outcomes trial
TCAS temperature control during aneurysm surgery
TexCAPS Texas coronary atherosclerosis prevention study
TeqCES Tequin® clinical experience study
TheraP TheraSource™ Pd-103 for prevention of restenosis; sponsor: Theragenics Corporation [TheraSource™ intravascular brachytherapy system]
TIGER-PA tirofiban given in the emergency room before primary angioplasty
TIME trial of invasive vs. medical therapy in elderly patients with chronic CAD
TIMI thrombolysis in myocardial infarction;
thrombin inhibition in myocardial infarction
TNT treating to new targets
TOAT the open artery trial
TONE trial of nonpharmacologic interventions in the elderly
TOP treatment of osteoporosis with PTH [ALX1-11, a recombinant parathyroid hormone (PTH) formulation]; sponsor: NPS Pharmaceuticals
TOPIC tobramycin once-daily prescribing in cystic fibrosis
TRACE trandolapril cardiac evaluation study
trial of genetic assessment in breast cancer
TRAFFIC therapeutic angiogenesis with FGF-2 (fibroblast growth factor) for intermittent claudication; sponsor: Chiron Corporation
TRANSCEND telmisartan [Micardis®] randomized assessment study in ace intolerant subjects with cardiovascular disease
TREAT tranilast restenosis following angioplasty trial
TREND trial on reversing endothelial dysfunction
TROPHY trial for preventing hypertension;
TRUST Tenax® for the prevention of restenosis and acute thrombotic complications. A useful stent trial [Tenax-XR, a silicon carbide-coated stent]; sponsor: Biotronik, Inc.
TTT4CNV transpupillary thermotherapy for choroidal neovascularization
TURBO the ultrasound removal of blood clots in vein grafts; Angiosonics
TUSS tuberculosis ultraviolet shelter study
UK-HEART United Kingdom heart failure evaluation and assessment of risk trial
UKPDS United Kingdom perspective diabetes study
UNAIDS PETRA United Nations programme on HIV/AIDS perinatal transmission trial
VA-HIT Veterans Administration HDL intervention trial
Val-HeFT valsartan heart failure trial;
VALIANT valsartan in acute myocardial infarction trial;
Vascular Architects femoropopliteal suboptimal angioplasty aSpire™ stent trial; sponsor: Vascular Architects
VALUE valsartan antihypertensive long-term use evaluation;
VANILA ventricular arrhythmia needing intravenous lidocaine/amiodarone
VANQWISH Veterans Affairs non–Q-wave infarction strategies in hospital
VERT vertebral efficacy with risedronate therapy; risedronate (Actonel®)
VICTORY elective and acute stenting of coronary arteries on Express™ [coronary stent system]; sponsor: Boston Scientific
VIGOR Vioxx® gastrointestinal outcomes research
VINTAGE MI vascular interaction with age in myocardial infarction
VISION vascular intervention study with ionizing radiation; sponsor: Guidant Corp. [Galileo™ intravascular radiotherapy system]
VISP vitamin intervention for stroke prevention
VITATOPS vitamins to prevent stroke
VIVA VEGF (vascular endothelial growth factor) in ischemia for vascular angiogenesis
VMAC vasodilation in the management of acute congestive heart failure;
WARCEF warfarin-aspirin reduced cardiac ejection fraction
WARIS-II warfarin-aspirin reinfarction study
WARSS warfarin aspirin recurrent stroke study
WASID warfarin-asprin symptomatic intracranial disease study
WATCH warfarin & antiplatelet therapy in chronic CHF
women atorvastatin trial on cholesterol
WAVE women's angiographic vitamins and estrogen trial
WEARIT wearable cardioverter-defibrillator investigational trial
WIHS women's interagency HIV study
WINS women’s intervention nutrition study
WISE women's ischemia syndrome evaluation;
WIZARD weekly intervention with Zithromax® against atherosclerosis and related disorders
Women's HOPE Women's health, osteoporosis, progestin, and estrogen study
WRIST Washington radiation for in-stent restenosis trial
XISHF xamoterol in severe heart failure
X-TRACT X-Sizer™ for treatment of thrombus and atherosclerosis in coronary interventions trial X-Sizer
ZEUS Zomaril™ efficacy/utility and safety;
ZIPP Zoladex® (goserelin acetate implant) in premenopausal patients

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