Positive data in trial of Xarelto to reduce Stroke risk-Bayer HealthCare

Janssen and Bayer HealthCare announced results from the X-VeRT trial, demonstrating once-daily Xarelto (rivaroxaban) may be an alternative to vitamin K antagonists (VKA) in treating and reducing the risk of blood clots in non-valvular Atrial Fibrillation (NVAF) patients undergoing elective cardioversion, a medical procedure to reset the heartbeat back to a regular rhythm. In this 1,504 patient Phase IIIb exploratory trial, compared to VKA therapies such as warfarin, 0.51 percent of patients treated with Xarelto were observed to have a primary efficacy outcome of stroke, transient ischemic attack, peripheral embolism, myocardial infarction or cardiovascular death compared with 1.02 percent of patients treated with VKA.

In addition, 0.61 percent of patients treated with Xarelto were also observed to have a major bleeding event compared with 0.81 percent for VKA. The differences in both the efficacy and safety primary endpoints were not statistically significant, as this trial was not designed to determine statistical significance. X-VeRT is part of the EXPLORER global cardiovascular research program which includes 11 trials assessing the safety and efficacy of rivaroxaban in high-risk patient populations, including those with chronic heart failure, coronary artery disease, peripheral artery disease, acute coronary syndrome and embolic stroke of undetermined source.