Warfarin Versus Aspirin in Patients With Reduced Cardiac Ejection Fraction (WARCEF): Rationale, Objectives, and Design
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Accession number;06A0128126
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| Title;Warfarin Versus Aspirin in Patients With Reduced Cardiac Ejection Fraction (WARCEF): Rationale, Objectives, and Design |
| Author;
PULLICINO PATRICK
(Dep. Of Neurology And Neurosciences, New Jersey Medical School, Umdnj, Newark, New Jersey)
THOMPSON JOHN L.P.
(Dep. Of Biostatistics, Mailman School Of Public Health, Columbia Univ., New York, New York)
BARTON BRUCE
(Maryland Medical Res. Inst., Baltimore, Maryland)
LEVIN BRUCE
(Dep. Of Biostatistics, Mailman School Of Public Health, Columbia Univ., New York, New York)
GRAHAM SUSAN
(Div. Of Cardiology, Dep. Of Medicine, State Univ. Of New York At Buffalo)
FREUDENBERGER RONALD S.
(Heart Failure And Transplant Cardiology Program, Dep. Of Medicine, Robert Wood Johnson Medical School, New Brunswick ...)
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Journal Title;J Card Fail
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Journal Code:W1342A
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ISSN:1071-9164
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VOL.12;NO.1;PAGE.39-46(2006)
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| Figure&Table&Reference;FIG.1, TBL.5, REF.44 |
| Pub. Country;United States |
| Language;English |
| Abstract;Warfarin is widely prescribed for patients with heart failure without level 1 evidence, and an adequately powered randomized study is needed. The Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction study is a National Institutes of Health-funded, randomized, double-blind clinical trial with a target enrollment of 2860 patients. It is designed to test with 90% power the 2-sided primary null hypothesis of no difference between warfarin (International Normalized Ratio 2.5-3) and aspirin (325 mg) in 3- to 5-year event-free survival for the composite endpoint of death, or stroke (ischemic or hemorrhagic) among patients with cardiac ejection fraction .LEQ.35% who do not have atrial fibrillation or mechanical prosthetic heart valves. Secondary analyses will compare warfarin and aspirin for reduction of all-cause mortality, ischemic stroke, and myocardial infarction (MI), balanced against the risk of intracerebral hemorrhage, among women and African Americans; and compare warfarin and aspirin for prevention of stroke alone. Randomization is stratified by site, New York Heart Association (NYHA) heart class (I vs II-IV), and stroke or transient ischemic attack (TIA) within 1 year before randomization versus no stroke or TIA in that period. NYHA class I patients will not exceed 20%, and the study has a target of 20% (or more) patients with stroke or TIA within 12 months. Randomized patients receive active warfarin plus placebo or active aspirin plus placebo, double-blind. The results should help guide the selection of optimum antithrombotic therapy for patients with left ventricular dysfunction. Copyright 2006 Elsevier B.V., Amsterdam.All rights reserved. |
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