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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Feb 2018

At a glance

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

    • 01 Feb 2018 Results of post-hoc analysis published in the Clinical Cardiology
    • 12 Dec 2017 Results of exposure-response analysis presented at the 59th Annual Meeting and Exposition of the American Society of Hematology
    • 30 Aug 2017 Results demonstrating timing of trial stoppage for non-inferiority trials and interpretation based upon events from this trial, presented at the ESC Congress 2017: Annual Congress of the European Society of Cardiology.
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