Journal article
Design of a multicenter randomized trial for the stroke prevention in atrial fibrillation study
Stroke (1970), Vol.21(4), pp.538-545
1990
DOI: 10.1161/01.STR.21.4.538
Abstract
Individuals with nonvalvular atrial fibrillation are at increased risk of stroke. The Stroke Prevention in Atrial Fibrillation Study is a 15-center randomized clinical trial examining the risks and benefits of low-intensity warfarin (prothrombin time of 1.3-1.8 times control) and aspirin (325 mg/day) in patients with constant or intermittent atrial fibrillation. Candidates for anticoagulation (group I) are randomized to receive warfarin in an open-label fashion, aspirin, or placebo; the last two treatments are given in a double-blind fashion. Warfarin-ineligible patients (group II) are randomized to receive aspirin or placebo in a double-blind fashion. Primary end points are ischemic stroke and systemic embolism. Secondary end points are death, transient ischemic attack, myocardial infarction, and unstable angina pectoris. Analysis is based on the intention-to-treat principle. The anticipated rate of primary end points in patients receiving placebo is 6%/yr. The sample size of 1,644 patients is based on a projected reduction in the rate of primary end points of 50% by warfarin and of 33% by aspirin (beta = 0.2, alpha = 0.05). Patient entry commenced in June 1987 and will continue for 3 years, with an additional year of follow-up. High-risk subsamples identified by clinical and echocardiographic criteria are sought prospectively.
Details
- Title: Subtitle
- Design of a multicenter randomized trial for the stroke prevention in atrial fibrillation study
- Creators
- D. C Anderson - Hennepin CountyR. W Asinger - Hennepin CountyS. W Sharkey - Hennepin CountyG. C Flaker - University of MissouriR Webel - University of MissouriB Nolte - University of MissouriP Stevenson - University of MissouriJ Byer - University of MissouriW Wright - University of MissouriJ. H Chesebro - Hennepin CountyD. O Wiebers - Mayo ClinicA. E Holland - Mayo ClinicS. M Newburg - Hennepin CountyC. C Farmer - Hennepin CountyK Wang - Abbott Northwestern HospitalS. R Bundlie - Hennepin CountyR. L Koller - Hennepin CountyW. M Jagiella - Hennepin CountyS Kreher - Hennepin CountyC. R Jorgensen - Hennepin CountyStroke Prevention in Atrial Fibrillation Investigators
- Contributors
- Donald D Brown (Contributor) - University of Iowa, Cardiovascular Medicine
- Resource Type
- Journal article
- Publication Details
- Stroke (1970), Vol.21(4), pp.538-545
- DOI
- 10.1161/01.STR.21.4.538
- ISSN
- 0039-2499
- eISSN
- 1524-4628
- Publisher
- Lippincott Williams & Wilkins
- Language
- English
- Date published
- 1990
- Academic Unit
- Cardiovascular Medicine; Internal Medicine
- Record Identifier
- 9984359574702771
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