Pullicino, P. and Thompson, J.L.P. and Barton, B. and Levin, B. and Graham, S. and Freudenberger, R.S. (2006) Warfarin versus aspirin in patients with reduced cardiac ejection fraction (WARCEF): rationale, objectives and design. Journal of Cardiac Failure, 12 (1). pp. 39-46. ISSN 1071-9164.
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Background: Warfarin is widely prescribed for patients with heart failure without level 1 evidence, and an adequately powered randomized study is needed. Methods and Results: 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 <= 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. Conclusion: The results should help guide the selection of optimum antithrombotic therapy for patients with left ventricular dysfunction.
|Uncontrolled keywords:||stroke heart failure anticoagulation ejection fraction|
|Subjects:||R Medicine > R Medicine (General)|
|Divisions:||Faculties > Science Technology and Medical Studies > Kent Institute of Medicine and Health Sciences (KIMHS)|
|Depositing User:||M.P. Stone|
|Date Deposited:||08 Sep 2008 23:06|
|Last Modified:||08 Sep 2008 23:06|
|Resource URI:||http://kar.kent.ac.uk/id/eprint/12242 (The current URI for this page, for reference purposes)|
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