Warfarin versus aspirin in patients with reduced cardiac ejection fraction (WARCEF): rationale, objectives and design

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. (The full text of this publication is not available from this repository)

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Official URL
http://dx.doi.org/10.1016/j.cardfail.2005.07.007

Abstract

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.

Item Type: Article
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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