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: 19 Mar 2017

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

    • 07 Mar 2017 Results evaluating the consistency of treatment effect of rivaroxaban versus warfarin across the full range of baseline creatinine clearance (CrCl), published in the Circulation
    • 16 Nov 2016 Results of analysis assessing the association between selective serotonin reuptake inhibitors use and bleed risk in anticoagulated patients with atrial fibrillation in the ROCKET AF trial, presented at the 89th Annual Scientific Sessions of the American Heart Association.
    • 29 Aug 2016 Results published in Bayer media release.
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