Warfarin versus aspirin in patients with reduced cardiac ejection fraction (WARCEF): rationale, objectives, and design.
J Card Fail
; 12(1): 39-46, 2006 Feb.
Article
em En
| MEDLINE
| ID: mdl-16500579
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.
Buscar no Google
Base de dados:
MEDLINE
Assunto principal:
Volume Sistólico
/
Varfarina
/
Inibidores da Agregação Plaquetária
/
Baixo Débito Cardíaco
/
Aspirina
/
Anticoagulantes
Tipo de estudo:
Clinical_trials
Limite:
Female
/
Humans
Idioma:
En
Ano de publicação:
2006
Tipo de documento:
Article