Bayer HealthCare begins new phase III Xarelto trial

Bayer HealthCare has initiated a new phase III trial of its oral anticoagulant Xarelto (rivaroxaban) among patients with chronic heart failure and significant coronary artery disease.

To be carried out in partnership with Janssen, the Commander-HF study will assess the safety and efficacy of 2.5 mg twice daily rivaroxaban compared to placebo in reducing the risk of death, myocardial infarction or stroke among 5,000 test subjects.

Xarelto is the first novel oral anticoagulant to be evaluated in this patient group, who are at high risk of complications following hospitalisation for exacerbation of their heart failure.

The US Food and Drug Administration granted a fast track designation process for Commander-HF to help facilitate the development process.

Dr Kemal Malik, member of the Bayer HealthCare executive committee and head of global development, said: "Commander-HF will assess whether the addition of low-dose rivaroxaban on top of standard therapy can help reduce the risk of death, heart attack or stroke in this high-risk patient group following hospitalisation."

This comes after the firm also launched a phase IIIb trial of Xarelto for the treatment of non-valvular atrial fibrillation among patients undergoing percutaneous coronary intervention with stent placement earlier this week.