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

Publication/Presentation Date

2-1-2006

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 < or =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.

Volume

12

Issue

1

First Page

39

Last Page

46

ISSN

1532-8414

Disciplines

Cardiology | Medical Sciences | Medical Specialties | Medicine and Health Sciences

PubMedID

16500579

Department(s)

Department of Medicine, Cardiology Division, Department of Medicine Faculty

Document Type

Article

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