Rivaroxaban vs. warfarin in Japanese patients with atrial fibrillation – the J-ROCKET AF study –

Circ J. 2012;76(9):2104-11. doi: 10.1253/circj.cj-12-0454. Epub 2012 Jun 5.


Background: The global ROCKET AF study evaluated once-daily rivaroxaban vs. warfarin for stroke and systemic embolism prevention in patients with atrial fibrillation (AF). A separate trial, J-ROCKET AF, compared the safety of a Japan-specific rivaroxaban dose with warfarin administered according to Japanese guidelines in Japanese patients with AF.

Methods and results: J-ROCKET AF was a prospective, randomized, double-blind, phase III trial. Patients (n=1,280) with non-valvular AF at increased risk for stroke were randomized to receive 15 mg once-daily rivaroxaban or warfarin dose-adjusted according to Japanese guidelines. The primary objective was to determine non-inferiority of rivaroxaban against warfarin for the principal safety outcome of major and non-major clinically relevant bleeding, in the on-treatment safety population. The primary efficacy endpoint was the composite of stroke and systemic embolism. Non-inferiority of rivaroxaban to warfarin was confirmed; the rate of the principal safety outcome was 18.04% per year in rivaroxaban-treated patients and 16.42% per year in warfarin-treated patients (hazard ratio [HR] 1.11; 95% confidence interval 0.87-1.42; P<0.001 [non-inferiority]). Intracranial hemorrhage rates were 0.8% with rivaroxaban and 1.6% with warfarin. There was a strong trend for a reduction in the rate of stroke/systemic embolism with rivaroxaban vs. warfarin (HR, 0.49; P=0.050).

Conclusions: J-ROCKET AF demonstrated the safety of a Japan-specific rivaroxaban dose and supports bridging the global ROCKET AF results into Japanese clinical practice.

Trial registration: ClinicalTrials.gov NCT00494871.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anticoagulants / administration & dosage*
  • Anticoagulants / adverse effects
  • Atrial Fibrillation / complications*
  • Atrial Fibrillation / drug therapy
  • Double-Blind Method
  • Embolism / etiology
  • Embolism / prevention & control*
  • Female
  • Humans
  • Intracranial Hemorrhages / chemically induced
  • Male
  • Middle Aged
  • Morpholines / administration & dosage*
  • Morpholines / adverse effects
  • Prospective Studies
  • Rivaroxaban
  • Stroke / etiology
  • Stroke / prevention & control*
  • Thiophenes / administration & dosage*
  • Thiophenes / adverse effects
  • Warfarin / administration & dosage*
  • Warfarin / adverse effects


  • Anticoagulants
  • Morpholines
  • Thiophenes
  • Warfarin
  • Rivaroxaban

Associated data

  • ClinicalTrials.gov/NCT00494871