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

Pullicino, Patrick, Thompson, John L. P., Barton, Bruce, Levin, Bruce, Graham, Susan, Freudenberger, Ronald 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. (doi:10.1016/j.cardfail.2005.07.007) (The full text of this publication is not currently available from this repository. You may be able to access a copy if URLs are provided)

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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
DOI/Identification number: 10.1016/j.cardfail.2005.07.007
Uncontrolled keywords: stroke heart failure anticoagulation ejection fraction
Subjects: R Medicine > R Medicine (General)
Divisions: Faculties > Sciences > Kent Institute of Medicine and Health Sciences (KIMHS)
Depositing User: M.P. Stone
Date Deposited: 08 Sep 2008 23:06 UTC
Last Modified: 28 May 2019 13:48 UTC
Resource URI: https://kar.kent.ac.uk/id/eprint/12242 (The current URI for this page, for reference purposes)
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