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A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects With Nonvalvular Atrial Fibrillation

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Trial Profile

A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects With Nonvalvular Atrial Fibrillation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Oct 2023

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At a glance

  • Drugs Apixaban (Primary) ; Warfarin
  • Indications Embolism; Stroke; Thromboembolism
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ARISTOTLE
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 28 Aug 2023 Results assessing the association between baseline characteristics with BMP10 concentrations, and if repeated BMP10 measurements at 2 months improve the prognostication of ischemic stroke or systemic embolism and other cardiovascular events in patients with AF , presented at the ESC Congress 2023 - Annual Congress of the European Society of Cardiology
    • 16 May 2022 Data from ARISTOTLE: NCT00412984; AVERROES: NCT00496769; AMPLIFY: NCT00643201; AMPLIFY-EXT: NCT00633893; ADVANCE-1: NCT00371683; ADVANCE-2: NCT00452530; ADVANCE-3: NCT00423319 studies has been used to assess apixaban use in obese patients published in the American Journal of Cardiovascular Drugs
    • 04 Apr 2022 Results of a pooled analysis ((RE-LY and ARISTOTLE) analysis assessed the usefulness of biomarker-based ABC-AF scores to estimate the risks of stroke and bleeding presented at the 71st Annual Scientific Session of the American College of Cardiology

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