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A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation

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Trial Profile

A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Jan 2022

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At a glance

  • Drugs Rivaroxaban (Primary) ; Warfarin
  • Indications Stroke; Thromboembolism
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ROCKET-AF
  • Sponsors Bayer HealthCare; Janssen Research & Development

    • Most Recent Events

    • 05 Jan 2022 Results of meta-analysis of 4 studies (RE-LY, ROCKET AF, ARISTOTLE, and ENGAGE AF-TIMI 48) assessing the effect modification with a Cox regression model as well as across the spectrum of age as a continuous covariate, published in the Circulation.
    • 08 Feb 2021 Results of an analysis assessing the baseline characteristics and outcomes in patients enrolled in Latin America compared with the rest of the world published in the American Heart Journal
    • 12 Nov 2020 Results of systematic review and meta-analysis of 4 studies (RE-LY, ROCKET AF, ARISTOTLE, and ENGAGE AF-TIMI 48) assessing efficacy and safety of DOAC agents compared to warfarin for patients with various levels of anticoagulation control as reflected by their time in therapeutic range (TTR), published in the American Journal of Cardiology.

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