Phase 3 study of rivaroxaban for the treatment of stroke associated with atrial fibrillation (AF)

Johnson & Johnson Pharmaceutical Research & Development announced results from its Phase 3 study of rivaroxaban in non-valvular atrial fibrillation (AF) patients to reduce the risk of stroke and non-CNS systemic embolism.  This study, also known as the ROCKET AF trial, was a prospective, randomized, double-blind, double-dummy parallel group outcomes study comparing once-daily rivaroxaban (20mg, or 15mg for patients with moderate renal impairment) with dose-adjusted warfarin in 14,264 patients.

The trial demonstrated that rivaroxaban given once daily was superior to warfarin for the primary efficacy endpoint, showing a 21% relative risk reduction (RRR) for stroke and non-CNS systemic embolism in the pre-specified on-treatment population (1.7% vs. 2.2%, respectively, p=0.015). Additionally, in the intent to treat population (ITT), which followed all patients randomized 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 (2.1% vs. 2.4%, p<0.001 for non-inferiority).

Rivaroxaban is a novel oral anticoagulant being evaluated for the prevention and treatment of a broad range of disorders in which blood clotting plays a major role.

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