Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel: Difference between revisions
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==Source of Data <small>(Where is this data on this page coming from: publication, principal investigator, or co-investigator)</small>== | ==Source of Data <small>(Where is this data on this page coming from: publication, principal investigator, or co-investigator)</small>== | ||
The content of the clinical trial wiki consists of fields that have been suggested by the World Health Organization and wwww.clinicaltrials.gov. | The content of the clinical trial wiki consists of fields that have been suggested by the World Health Organization and wwww.clinicaltrials.gov. | ||
Revision as of 20:44, 2 June 2009
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Complete Title of Study
Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel
Study Acronym (The trial's abbreviation if there is one)
3T/2R
Principal Investigator, Co-investigators, and Collaborating Institutions
Principal investigator: Marco Valgimigli, MD, PhD
Institution: Universitaria di Ferrara, Ferrara, Fe, Italy
Overview of Trial
The goal of the study was to evaluate whether adding tirofiban, administered at high bolus dose on top of aspirin and clopidogrel will lead to a lower rate of periprocedural myocardial infarction after percutaneous coronary intervention in elective patients presenting with aspirin and/or clopidogrel resistance.
Disease State(s) Studied (e.g. acute MI, breast cancer, etc.)
Coronary artery disease
Study Phase (e.g. Phase I,II,III,IV) Study Phases are defined here
Phase IV
Study Design (e.g. multicenter, randomized, double blind, placebo controlled)
Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Treatment, Parallel Assignment, Efficacy Study
Study Arms and How They Were Treated (Intervention) (Explanation here)
263 patients were randomized to either an experimental arm (Aspirin, clopidogrel, Unfractioned heparin or bivalirudin plus tirofiban infusion given at high bolus dose plus standard 14-24 hour infusion) or a placebo arm (Saline infusion administered for 14-24 hours).
Primary Pre-Specified Endpoint
Troponin I or T elevation ratio at least three times the upper limit of normal
Secondary Endpoints
The incidence of myocardial infarction defined as elevation of CK-MB >1, ≥3 or ≥5 times the ULN in one or more blood samples (time frame: 30 days), Elevation of troponin levels above upper limit of normal in ratios different from the primary endpoint (within 30 days), Bleeding rates (time frame: 30 days), Stent thrombosis with the first year of follow-up, and the rate of major adverse cardiovascular events at 30 days and 1 year
Inclusion Criteria
Patients older than 18 years scheduled for coronary angiography and/or PCI with stable or unstable troponin and CK-MB negative coronary artery disease showing aspirin and or clopidogrel resistance (ACR.)
Exclusion Criteria
- Inability to provide informed consent
- Life expectancy of < 1 year
- Evolving or ongoing myocardial infarction (MI) (Persistence of or developing Q wave or ST segment elevation at ECG with or without typical chest pain or typical rapid rise and fall CK-MB or new LBBB) or patients in whom the treating physician intends to use a Gp IIB/IIIa inhibitors
- Administration of any GP IIb/IIIa receptor antagonist, anticoagulation, or lytic therapy in the previous 30 days
- Serum creatinine > 2.5 mg/dl (221 micromol/L)
- Ongoing bleeding or bleeding diathesis or contraindication for anticoagulation or increase bleeding risk or history of bleeding in the last 1 year
- Previous stroke or TIA or any intracranial pathology in the last six months
- Major surgery or trauma within the previous six weeks
- Platelet count < 100.000 per cubic mm or HCT ,33% or Hb < 11 gm/dL
- Subjects who received low-molecular-weight heparin within the 24 hours prior to randomization
- Subjects with an allergy or intolerance to aspirin, heparin, clopidogrel, or tirofiban
- Patients with severe hypertension (SBP > 180 mm Hg or DBP > 110 mm Hg) or in cardiogenic shock (SBP 80 mm Hg or below for > 30 minutes) or requiring IABP
Outcome: Primary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
None reported
Outcome: Secondary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
None reported
Outcome: Exploratory endpoints (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
None reported
Outcome: Safety endpoints (Report both relative risk and absolute risk as well as number needed to harm if available)
None reported
Conclusions of the Investigators (Quote the investigators conclusions here)
None reported
Commentary, Discussion and Limitations of the Trial (Anyone can add comments)
None reported
Slides
None reported
Video Commentary
None reported
References (How to insert a reference)
None reported
External sites for further information (How to insert links)
None reported
Detailed information about the trial
Ages
__ years to ___ years
Gender (Indicate whether men, women or both were enrolled)
None reported
Accepts Healthy Volunteers (Answer yes or no)
None reported
Enrollment Period (Study start and end date)
None reported
Recruitment Status (explanation)
None reported
Enrollment (Total number of patients enrolled)
None reported
Study Sponsor (e.g. Investigator initiated or company name)
None reported (this may not have yet been ascertained)
Source of Data (Where is this data on this page coming from: publication, principal investigator, or co-investigator)
The content of the clinical trial wiki consists of fields that have been suggested by the World Health Organization and wwww.clinicaltrials.gov.