Action To Control Cardiovascular Risk In Diabetes

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

External sites for further information (How to insert links)
None reported

Ages
40 years to 79 years

Gender (Indicate whether men, women or both were enrolled)
Both

Accepts Healthy Volunteers (Answer yes or no)
No

Enrollment Period (Study start and end date)
Study start date: September 1999

Estimated study completion date: June 2010

Primary completion date: June 2009

Recruitment Status (explanation)
Active, not recruiting

Enrollment (Total number of patients enrolled)
10251

Study Sponsor (e.g. Investigator initiated or company name)
National Heart, Lung, and Blood Institute (NHLBI)

Source of Data (Where is this data on this page coming from: publication, principal investigator, or co-investigator)
National Heart, Lung, and Blood Institute (NHLBI)

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