Bayer releases Rivaroxaban Phase III Rocket AF trial

Importantly, rates of bleeding were similar to warfarin, and bleeding events most concerning to physicians and patients, including intracranial hemorrhage, critical organ bleed, and bleeding-related death, were significantly lower in the Rivaroxaban group.

Bayer‘s Rocket AF is undertaken in the prevention of stroke in patients with AF, comparing once-daily Rivaroxaban to dose-adjusted warfarin.

Reportedly, for the primary efficacy endpoint, Rivaroxaban was superior to warfarin, delivering a 21% relative risk reduction in stroke and non-CNS systemic embolism in the pre-specified on treatment population.

Additionally, in the intent to treat (ITT) population which followed all patients randomised in the trial until its completion, whether or not they completed the full course of therapy or switched to other options, Rivaroxaban showed comparable benefits to warfarin.

Rocket AF Executive Steering Committee chair Werner Hacke said that anticoagulation with warfarin is effective in preventing strokes in patients with atrial fibrillation and has been the standard of care for more than half a century.

"The Rocket AF study has shown that once-daily Rivaroxaban promises patients improved protection from stroke, with good safety and added convenience," Hacke said.

Duke University Clinical Research vice chancellor and study co-chairman Robert Califf said that given the prevalence and morbidity associated with atrial fibrillation, and the well-known difficulties with warfarin use, it was exciting to have an alternative which was documented in this study to be effective with no increase in significant bleeding.