Design of a multicenter randomized trial for the stroke prevention in atrial fibrillation study

D. C Anderson; R. W Asinger; S. W Sharkey; G. C Flaker; R Webel; B Nolte; P Stevenson; J Byer; W Wright; J. H Chesebro; D. O Wiebers; A. E Holland; S. M Newburg; C. C Farmer; K Wang; S. R Bundlie; R. L Koller; W. M Jagiella; S Kreher; C. R Jorgensen; Stroke  Prevention  in Atrial  Fibrillation  Investigators

doi:10.1161/01.STR.21.4.538

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Design of a multicenter randomized trial for the stroke prevention in atrial fibrillation study

Journal article

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Design of a multicenter randomized trial for the stroke prevention in atrial fibrillation study

D. C Anderson, R. W Asinger, S. W Sharkey, G. C Flaker, R Webel, B Nolte, P Stevenson, J Byer, W Wright, J. H Chesebro, …

Stroke (1970), Vol.21(4), pp.538-545

1990

DOI: 10.1161/01.STR.21.4.538

PMID: 2183405

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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.

Biological and medical sciences

Blood. Blood coagulation. Reticuloendothelial system

Medical sciences

Pharmacology. Drug treatments

Details

Title: Subtitle: Design of a multicenter randomized trial for the stroke prevention in atrial fibrillation study
Creators: D. C Anderson - Hennepin County
R. W Asinger - Hennepin County
S. W Sharkey - Hennepin County
G. C Flaker - University of Missouri
R Webel - University of Missouri
B Nolte - University of Missouri
P Stevenson - University of Missouri
J Byer - University of Missouri
W Wright - University of Missouri
J. H Chesebro - Hennepin County
D. O Wiebers - Mayo Clinic
A. E Holland - Mayo Clinic
S. M Newburg - Hennepin County
C. C Farmer - Hennepin County
K Wang - Abbott Northwestern Hospital
S. R Bundlie - Hennepin County
R. L Koller - Hennepin County
W. M Jagiella - Hennepin County
S Kreher - Hennepin County
C. R Jorgensen - Hennepin County
Stroke 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
PMID: 2183405
NLM abbreviation: Stroke
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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