Action To Control Cardiovascular Risk In Diabetes: Difference between revisions
No edit summary |
|||
| Line 41: | Line 41: | ||
== Inclusion Criteria == | == Inclusion Criteria == | ||
* Diagnosed with type 2 diabetes mellitus, as determined by the new American Diabetes Association guidelines, which include a fasting plasma glucose level greater than 126 mg/dl (7.0 mmol/l), or a 2-hour postload value in the oral glucose tolerance test of greater than 200 mg/dl, with confirmation by a retest | |||
* For participants aged 40 years or older, history of CVD (heart attack, stroke, history of coronary revascularization, history of peripheral or carotid revascularization, or demonstrated angina) | |||
* For participants aged 55 years or older, a history of CVD is not required, but participant must be considered to be at high risk for experiencing a CVD event due to existing CVD, subclinical disease, or 2+ CVD risk factors | |||
* HbA1c 7.5%-9% (if on more drugs) or 7.5%-11% (if on fewer drugs) | |||
==Exclusion Criteria== | ==Exclusion Criteria== | ||
Revision as of 15:46, 9 June 2009
Complete Title of Study
Action to Control Cardiovascular Risk in Diabetes (ACCORD)
Study Acronym (The trial's abbreviation if there is one)
ACCORD
Principal Investigator, Co-investigators, and Collaborating Institutions
Study Director: Denise Simons-Morton, MD, PhD of the National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: William Friedewald, MD of Columbia University, New York, NY
Principal Investigator: Robert Byington, PhD of Wake Forest University, Winston-Salem, NC
Overview of Trial
The goal of the ACCORD study was to evaluate the ability of intensive glycemic control, intensive blood pressure control, and multiple lipid management to prevent major cardiovascular events in 10,251 type 2 diabetes patients.
Disease State(s) Studied (e.g. acute MI, breast cancer, etc.)
- Atherosclerosis
- Cardiovascular Diseases
- Hypercholesterolemia
- Hypertension
- Diabetes Mellitus, Type 2
- Coronary Disease
Study Phase (e.g. Phase I,II,III,IV) Study Phases are defined here
Phase III
Study Design (e.g. multicenter, randomized, double blind, placebo controlled)
Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Study Arms and How They Were Treated (Intervention) (Explanation here)
- Experimental: A strategy of intensive glycemia treatment to HbA1 less than 6%
- Active Comparator: A strategy of multiple drugs to treat HbA1c to 7.0%-7.9%
- Experimental: A strategy of BP treatment for SBP less than 120 mm Hg
- Active Comparator: A strategy of BP treatment for SBP less than 140 mm Hg
- Experimental: Blinded fenofibrate + simvastatin 20-40 mg/d
Primary Pre-Specified Endpoint
First occurence of a major CVD event, specifically nonfatal heart attack, nonfatal stroke, or cardiovascular death (measured throughout the study) Time Frame: 5-1/2 years
Secondary Endpoints
Total mortality Time Frame: 5-1/2 years
Inclusion Criteria
- Diagnosed with type 2 diabetes mellitus, as determined by the new American Diabetes Association guidelines, which include a fasting plasma glucose level greater than 126 mg/dl (7.0 mmol/l), or a 2-hour postload value in the oral glucose tolerance test of greater than 200 mg/dl, with confirmation by a retest
- For participants aged 40 years or older, history of CVD (heart attack, stroke, history of coronary revascularization, history of peripheral or carotid revascularization, or demonstrated angina)
- For participants aged 55 years or older, a history of CVD is not required, but participant must be considered to be at high risk for experiencing a CVD event due to existing CVD, subclinical disease, or 2+ CVD risk factors
- HbA1c 7.5%-9% (if on more drugs) or 7.5%-11% (if on fewer drugs)
Exclusion Criteria
None reported
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)
None reported
The content of the clinical trial wiki consists of fields that have been suggested by the World Health Organization and wwww.clinicaltrials.gov.