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.
RCT Entities:
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: Renato D Lopes; David Garcia; Richard C Becker; Christopher B Granger; L Kristin Newby; John H Alexander; E Marc Jolicoeur; Allison Handler; Karen S Pieper; Antonio C Carvalho; Helio P Guimaraes; Dalton A F Chamone; Antonio C Baruzzi; Fabio S Machado; Ari Timerman; Antonio C Lopes Journal: J Thromb Thrombolysis Date: 2010-05 Impact factor: 2.300
Authors: Yuk M Law; Sumeet Sharma; Brian Feingold; Bret Fuller; William A Devine; Steven A Webber Journal: Pediatr Cardiol Date: 2012-08-10 Impact factor: 1.655
Authors: Patrick M Pullicino; Leslie A McClure; Virginia G Wadley; Ali Ahmed; Virginia J Howard; George Howard; Monika M Safford Journal: Stroke Date: 2009-10-15 Impact factor: 7.914
Authors: V P Alberts; M J Bos; P J Koudstaal; A Hofman; J C M Witteman; B H C Stricker; M M B Breteler Journal: Eur J Epidemiol Date: 2010-11 Impact factor: 8.082
Authors: Siqin Ye; Min Qian; Bo Zhao; Richard Buchsbaum; Ralph L Sacco; Bruce Levin; Marco R Di Tullio; Douglas L Mann; Patrick M Pullicino; Ronald S Freudenberger; John R Teerlink; J P Mohr; Susan Graham; Arthur J Labovitz; Conrado J Estol; Dirk J Lok; Piotr Ponikowski; Stefan D Anker; Gregory Y H Lip; John L P Thompson; Shunichi Homma Journal: Eur J Heart Fail Date: 2016-07-21 Impact factor: 15.534