Warfarin vs. Asprin in Reduced Ejection Fraction

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• Double-Blind Multicenter Study Warfarin (INR 2 – 3.5) vs. ASA (325mg) • Echo Core Lab to confirm site determined LVEF • Timeline Study Design Recruitment: October 2002 to January 2010 Follow-up ended: July 2011
Statistical Design • Primary null hypothesis No overall difference between warfarin (target INR 2.75) and aspirin (325 mg/day) in time to first to occur of ischemic stroke, intracerebral hemorrhage, or death. • = 0.05 two-sided for superiority • Power 80% for 17.8% HR reduction. (achieved 67% after recruitment curtailed) • Given long follow-up (6 yrs maximum), prespecified analysis provides for a time-varying treatment effect (treatment by time interaction) if hazards are nonproportional
Page 1 and 2: WARFARIN vs. ASPIRIN in REDUCED CAR
Page 3 and 4: Background • Heart failure patien
Page 5: Key Inclusion Criteria 1. Normal si
Page 9 and 10: Randomized, n Lost to Follow-up, n
Page 11 and 12: Baseline Medication Time in Therape
Page 13 and 14: Warfarin vs. Aspirin Hazard Ratios
Page 15 and 16: No. at risk Main Secondary Outcome
Page 17 and 18: Conclusions • No overall differen
Page 19 and 20: STUDY ORGANIZATION Sponsor - the Na

Warfarin vs. Asprin in Reduced Ejection Fraction

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