Phase III J-ROCKET AF Study of Bayer’s Xarelto (rivaroxaban) Meets Primary Endpoint
Conducted in Japan, the Phase III J-ROCKET AF study of Bayer’s once-daily Xarelto (rivaroxaban) in Japanese patients with non-valvular atrial fibrillation at risk of stroke met its primary endpoint, demonstrating non-inferiority versus warfarin for the principal safety outcome - the composite of major and non-major clinically relevant bleeding.
- (1888PressRelease) July 28, 2011 - In addition, J-ROCKET AF showed a 51% reduction of stroke and non-CNS systemic embolism in the Xarelto group compared with patients receiving warfarin. This was not statistically significant, as the trial was not powered for efficacy.
“The J-ROCKET AF study of rivaroxaban is the first and only pivotal, randomized, double-blind, double-dummy trial that has been undertaken in Japanese patients with atrial fibrillation, conducted with a Japan-specific dose and in full recognition of the Japanese Guideline environment. It is important that rivaroxaban demonstrated non-inferior safety and that there were numerically fewer intracranial hemorrhages versus warfarin. Since the J-ROCKET AF data are supportive of the results of the global ROCKET AF trial, I expect rivaroxaban to become an alternative to warfarin for Japanese patients suffering from non-valvular atrial fibrillation”, said Masatsugu Hori, M.D., Steering Committee Chairman and President of Osaka Medical Center for Cancer and Cardiovascular Diseases.
On April 14, 2011, Bayer communicated that Xarelto had been submitted for marketing approval in the prevention of stroke in patients with atrial fibrillation to the Japanese Ministry of Health, Labor and Welfare (MHLW).
Detailed Study Results
Event rates for the principal safety endpoint, the composite of major and non-major clinically relevant bleeding, were similar between the treatment groups: 18.0% and 16.4% per year for Xarelto and warfarin, respectively (hazard ratio [HR]=1.11; 95% Confidence Interval [CI] 0.87–1.42). Event rates for major bleeding were 3.0% and 3.6% per year (HR=0.85; 95% CI 0.50–1.43) and for non-major clinically relevant bleeding were 15.4% and 13.0% per year for Xarelto and warfarin, respectively (HR=1.20; 95% CI 0.92–1.56). Importantly, there was a trend toward lower rates of intracranial hemorrhages and bleeding-related death with Xarelto. These data are consistent with the results of the global ROCKET AF trial, which were reported at the Scientific Sessions of the American Heart Association (AHA) 2010 and showed similar rates of major and non-major clinically relevant bleeding in a diverse population of patients treated with once-daily Xarelto compared with dose-adjusted warfarin.
The relative reduction in the risk of stroke and non-CNS systemic embolism observed with Xarelto was 51% compared with warfarin (1.3% and 2.6% per year, respectively, HR=0.49; 95% CI 0.24–1.00). As the trial was powered for safety, not efficacy, this result did not reach statistical significance. This result is supported by the statistically significant reduction in stroke and non-CNS systemic embolism seen in the global ROCKET AF study in patients receiving active treatment with Xarelto, as well as the non-inferior efficacy demonstrated in the ITT population.
About J-ROCKET AF
In Japan, there are more than 800,000 individuals affected by atrial fibrillation. J-ROCKET AF (Japanese Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) is part of the large global clinical development program for Xarelto, which includes the global ROCKET AF Phase III trial involving 14,264 patients randomized, the results of which were reported at AHA (Chicago, 2010). J-ROCKET AF was a smaller study (1,280 patients randomized) that was performed to evaluate the safety of Xarelto versus warfarin in patients with non-valvular atrial fibrillation living in Japan.
J-ROCKET AF was a prospective, randomized, double-blind Phase III study in which Japanese patients were enrolled from over 160 centres across Japan. Mean on-treatment exposure to study drugs was 499 days and 481 days for Xarelto and warfarin, respectively. The study was led by Masatsugu Hori, M.D., President of Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan, and an academic Steering Committee of leading Japanese experts.
The primary objective of the study was to evaluate the safety of Xarelto, one tablet, once-daily versus dose-adjusted warfarin in patients with non-valvular atrial fibrillation in Japan. Non-inferiority was shown with respect to on-treatment bleeding, assessed as the composite of major and non-major clinically relevant bleeding events - the primary safety outcome. The primary efficacy endpoint was the composite of all-cause stroke and non-CNS systemic embolism.
Patients were randomized to 15 mg Xarelto once daily (10 mg in patients with moderate renal impairment at screening) or to warfarin with a target INR of 2.0-3.0 for patients aged
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