Warfarin versus aspirin in patients with reduced cardiac ejection fraction (WARCEF) : rationale, objectives, and design
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2006 |
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| Erschienen: |
2006 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
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| Enthalten in: |
Journal of cardiac failure - 12(2006), 1 vom: 30. Feb., Seite 39-46 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Pullicino, Patrick [VerfasserIn] |
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| Themen: |
5Q7ZVV76EI |
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| Anmerkungen: |
Date Completed 03.10.2006 Date Revised 21.11.2013 published: Print Citation Status MEDLINE |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM160928141 |
|---|
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| 100 | 1 | |a Pullicino, Patrick |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Warfarin versus aspirin in patients with reduced cardiac ejection fraction (WARCEF) |b rationale, objectives, and design |
| 264 | 1 | |c 2006 | |
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| 500 | |a Date Completed 03.10.2006 | ||
| 500 | |a Date Revised 21.11.2013 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Warfarin is widely prescribed for patients with heart failure without level 1 evidence, and an adequately powered randomized study is needed | ||
| 520 | |a 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 | ||
| 520 | |a CONCLUSION: The results should help guide the selection of optimum antithrombotic therapy for patients with left ventricular dysfunction | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 7 | |a Anticoagulants |2 NLM | |
| 650 | 7 | |a Platelet Aggregation Inhibitors |2 NLM | |
| 650 | 7 | |a Warfarin |2 NLM | |
| 650 | 7 | |a 5Q7ZVV76EI |2 NLM | |
| 650 | 7 | |a Aspirin |2 NLM | |
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| 700 | 1 | |a Barton, Bruce |e verfasserin |4 aut | |
| 700 | 1 | |a Levin, Bruce |e verfasserin |4 aut | |
| 700 | 1 | |a Graham, Susan |e verfasserin |4 aut | |
| 700 | 1 | |a Freudenberger, Ronald S |e verfasserin |4 aut | |
| 700 | 0 | |a WARCEF Investigators |e verfasserin |4 aut | |
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