ACTION TO CONTROL CARDIOVASCULAR RISK IN DIABETES (ACCORD) TRIAL

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The three specific primary ACCORD hypotheses are as follows. In middle-aged or older people with type 2 diabetes who are at high risk for having a cardiovascular disease (CVD) event because of existing clinical or subclinical CVD or CVD risk factors: 1) does a therapeutic strategy that targets HbA1c of < 6.0% reduce the rate of CVD events more than a strategy that targets a HbA1c of 7.0% to 7.9% (with the exception of achieving a median level of 7.5%)?; 2) in the context of good glycemic control, does a therapeutic strategy that uses a fibrate to raise LDL-C/lower triglyceride levels and uses a statin for treatment of LDL-C reduce the rate of CVD events compared to a strategy that only uses a statin for treatment of LDL-C?; 3) in the context of good glycemic control, does a therapeutic strategy that targets a systolic blood pressure (SBP) of <120mm Hg reduce the rate of CVD events compared to a strategy that targets a SBP of <140mm Hg? The primary outcome measure for the trial is the first occurrence of a major cardiovascular disease event, specifically nonf-atal myocardial infarction, non-fatal stroke, or cardiovascular death. The design is a randomized, multicenter, double 2X2 factorial design in 10,000 patients with type 2 diabetes mellitus. The trial is designed to test the effects on major CVD events of intensive glycemia control, of treatment to increase LDL-cholesterol and lower triglycerides (in the context of good LDL-C and glycemia control), and of intensive blood pressure control (in the context of good glycemia control). All 10,000 participants will be in the overarching glycemia trial. In addition, one 2X2 trial will also address the lipid question in 5,800 of the participants and the other 2X2 trial will address the blood pressure question in 4,200 of the participants. The 10,000 participants will be treated and followed for 4 to 8 years (approximate mean of 5.6 years) at approximately 60 clinical sites administratively located within 7 Clinical Center Networks in the United States and Canada. Recruitment will occur in two non-contiguous periods: an initial period that began in January, 2001, for the Vanguard Phase of the trial (during which 1184 participants were randomized) and then a subsequent period beginning in January, 2003, and ending in June, 2005. Follow-up is scheduled to end in June, 2009, with the primary results announced in early 2010.