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Warfarin versus aspirin in patients with reduced cardiac ejection fraction (WARCEF): rationale, objectives, and design.
J Card Fail 2006; 12(1):39-46JC

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.

Authors+Show Affiliations

Department of Neurology and Neurosciences, New Jersey Medical School, UMDNJ, Newark, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

16500579

Citation

Pullicino, Patrick, et al. "Warfarin Versus Aspirin in Patients With Reduced Cardiac Ejection Fraction (WARCEF): Rationale, Objectives, and Design." Journal of Cardiac Failure, vol. 12, no. 1, 2006, pp. 39-46.
Pullicino P, Thompson JL, Barton B, et al. Warfarin versus aspirin in patients with reduced cardiac ejection fraction (WARCEF): rationale, objectives, and design. J Card Fail. 2006;12(1):39-46.
Pullicino, P., Thompson, J. L., Barton, B., Levin, B., Graham, S., & 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.
Pullicino P, et al. Warfarin Versus Aspirin in Patients With Reduced Cardiac Ejection Fraction (WARCEF): Rationale, Objectives, and Design. J Card Fail. 2006;12(1):39-46. PubMed PMID: 16500579.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Warfarin versus aspirin in patients with reduced cardiac ejection fraction (WARCEF): rationale, objectives, and design. AU - Pullicino,Patrick, AU - Thompson,John L P, AU - Barton,Bruce, AU - Levin,Bruce, AU - Graham,Susan, AU - Freudenberger,Ronald S, AU - ,, PY - 2003/06/19/received PY - 2005/07/20/revised PY - 2005/07/22/accepted PY - 2006/2/28/pubmed PY - 2006/10/4/medline PY - 2006/2/28/entrez SP - 39 EP - 46 JF - Journal of cardiac failure JO - J. Card. Fail. VL - 12 IS - 1 N2 - 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. SN - 1532-8414 UR - https://www.unboundmedicine.com/medline/citation/16500579/Warfarin_versus_aspirin_in_patients_with_reduced_cardiac_ejection_fraction__WARCEF_:_rationale_objectives_and_design_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1071-9164(05)00715-3 DB - PRIME DP - Unbound Medicine ER -