Xarelto enters Phase III trial for Heart Failure and CAD

Bayer HealthCare and Janssen Research & Development, LLC announced the initiation of COMMANDER-HF, a pivotal Phase III clinical trial that will evaluate Xarelto (rivaroxaban) 2.5 mg twice daily in patients with Chronic Heart Failure (HF) and significant coronary artery disease (CAD). Rivaroxaban is the first novel oral anticoagulant to be evaluated in this patient group who remain at high-risk for complications following hospitalization for exacerbation of their HF.

The trial will assess the safety and efficacy of 2.5 mg twice daily rivaroxaban compared to placebo (on a background of standard treatment) in reducing the risk of death, myocardial infarction (MI) or stroke in 5,000 patients with chronic HF and significant CAD following hospitalization. The primary efficacy outcome is the composite of all-cause mortality, MI, or stroke. The principal safety outcome is the composite of fatal bleeding or bleeding into a critical space with a potential for permanent disability.