title: Rationale and design for the blood pressure intervention of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.
abstract: 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.
authors.affiliation: Memphis Veterans Affairs Medical Center, Memphis, Tennessee 38104, USA. william.cushman@va.gov
authors.forename: William C
authors.initials: WC
authors.lastname: Cushman
authors.forename: Richard H
authors.initials: RH
authors.lastname: Grimm
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Cutler
authors.forename: Gregory W
authors.initials: GW
authors.lastname: Evans
authors.forename: Sarah
authors.initials: S
authors.lastname: Capes
authors.forename: Marshall A
authors.initials: MA
authors.lastname: Corson
authors.forename: Laurie S
authors.initials: LS
authors.lastname: Sadler
authors.forename: Michael H
authors.initials: MH
authors.lastname: Alderman
authors.forename: Kevin
authors.initials: K
authors.lastname: Peterson
authors.forename: Alain
authors.initials: A
authors.lastname: Bertoni
authors.forename: Jan N
authors.initials: JN
authors.lastname: Basile
mesh_terms: 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
chemical_list: D000959:Antihypertensive Agents