Journal of Cardiac Failure
Volume 12, Issue 1 , Pages 39-46, February 2006

Warfarin Versus Aspirin in Patients With Reduced Cardiac Ejection Fraction (WARCEF): Rationale, Objectives, and Design

  • Patrick Pullicino, MD

      Affiliations

    • Department of Neurology and Neurosciences, New Jersey Medical School, UMDNJ, Newark, New Jersey
    • Corresponding Author InformationReprint requests: Patrick Pullicino, MD, Room 105, KIMHS, Research and Development Centre, University of Kent, Canterbury CT2 7PD, United Kingdom.
    • ,
  • John L.P. Thompson, PhD

      Affiliations

    • Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, New York
    • ,
  • Bruce Barton, PhD

      Affiliations

    • Maryland Medical Research Institute, Baltimore, Maryland
    • ,
  • Bruce Levin, PhD

      Affiliations

    • Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, New York
    • ,
  • Susan Graham, MD

      Affiliations

    • Division of Cardiology, Department of Medicine, State University of New York at Buffalo
    • ,
  • Ronald S. Freudenberger, MD

      Affiliations

    • Heart Failure and Transplant Cardiology Program, Department of Medicine, Robert Wood Johnson Medical School, New Brunswick, New Jersey
    • ,
  • on behalf of the WARCEF Investigators

Received 19 June 2003; received in revised form 20 July 2005; accepted 22 July 2005.

Newark, New Jersey; New York, New York; Baltimore, Maryland; Buffalo, New York; New Brunswick, New Jersey

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.

Key Words: Stroke, Heart failure, Anticoagulation, Ejection fraction

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 Funded by National Institutes of Health—National Institute of Neurological Disorders and Stroke, cooperative agreements U01 NS43975 and U01 NS39143Dr. Pullicino's current affiliation is Kent Institute of Medicine and Health Sciences, University of Kent, Canterbury, United Kingdom.

PII: S1071-9164(05)00715-3

doi:10.1016/j.cardfail.2005.07.007

Journal of Cardiac Failure
Volume 12, Issue 1 , Pages 39-46, February 2006

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