Apixaban for Reduction In Stroke and Other ThromboemboLic Events in Atrial Fibrillation (ARISTOTLE) trial: Design and rationale

摘要: Atrial fibrillation (AF) is associated with increased risk of stroke that can be attenuated vitamin K antagonists (VKAs). Vitamin antagonist use limited, in part, by the high incidence complications when patients' international normalized ratios (INRs) deviate from target range. The primary objective ARISTOTLE to determine if factor Xa inhibitor, apixaban, noninferior warfarin at reducing combined endpoint (ischemic or hemorrhagic) and systemic embolism patients AF least 1 additional for stroke. We have randomized 18,206 over 1,000 centers 40 countries. Patients were randomly assigned a 1:1 ratio receive apixaban using double-blind, double-dummy design. International are monitored (or placebo) adjusted aiming INR range 2 3 blinded, encrypted point-of-care device. Minimum treatment 12 months, maximum expected exposure 4 years. Time accrual 448 efficacy events will duration. key secondary objectives superior embolism, all-cause death. These tested after closed test procedure. noninferiority boundary 1.38; declared 95% CI excludes possibility outcome rate >1.38 times higher than warfarin. whether preventing embolism; has particular benefits warfarin-naive population; it reduces stroke, death; impacts bleeding.