ARTICLE | Clinical News

Xarelto meets safety endpoint in Phase III AF trial

July 25, 2011 11:39 PM UTC

Bayer AG (Xetra:BAY) said Xarelto rivaroxaban met the primary safety endpoint of non-inferiority to warfarin in the Japanese Phase III J-ROCKET AF trial to prevent stroke and non-CNS systemic embolism in patients with atrial fibrillation (AF). The safety endpoint measured the composite of major and non-major clinically relevant annual bleeding rates.

For efficacy, Xarelto led to a non-significant 51% relative reduction in the annual risk of stroke and non-CNS systemic embolism vs. warfarin. Bayer said the trial was not powered for the efficacy endpoint. Data were presented at the International Society on Thrombosis and Haemostasis meeting in Kyoto. ...