Rationale and design for the blood pressure intervention of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.
The Action to Control Cardiovascular Disease in Diabetes (ACCORD) blood pressure trial is an unmasked, open-label, randomized trial with a sample size of 4,733 participants. This report describes the rationale, design, and methods of the blood pressure interventions in ACCORD. Participants eligible for the blood pressure trial are randomized to 1 of 2 groups with different treatment goals: systolic blood pressure <120 mm Hg for the more intensive goal and systolic blood pressure <140 mm Hg for the less intensive goal. The primary outcome measure for the trial is the first occurrence of a major cardiovascular disease (CVD) event, specifically nonfatal myocardial infarction or stroke, or cardiovascular death during a follow-up period ranging from 4-8 years. The ACCORD blood pressure trial should provide the first definitive clinical trial data on the possible benefit of treating to a more aggressive systolic blood pressure goal in reducing CVD events in patients with diabetes mellitus.
Cushman
William C
WC
Memphis Veterans Affairs Medical Center, Memphis, Tennessee 38104, USA. william.cushman@va.gov
Grimm
Richard H
RH
Cutler
Jeffrey A
JA
Evans
Gregory W
GW
Capes
Sarah
S
Corson
Marshall A
MA
Sadler
Laurie S
LS
Alderman
Michael H
MH
Peterson
Kevin
K
Bertoni
Alain
A
Basile
Jan N
JN
D000959:Antihypertensive Agents / Q000627:therapeutic use; D001794:Blood Pressure; D003324:Coronary Artery Disease / Q000097:blood / Q000517:prevention & control*; D003924:Diabetes Mellitus, Type 2; D003925:Diabetic Angiopathies / Q000097:blood / Q000517:prevention & control*; D006801:Humans; D006973:Hypertension / Q000097:blood / Q000517:prevention & control*; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012107:Research Design
D000959:Antihypertensive Agents