Bayer initiates Phase III trial of Xarelto (rivaroxaban) to reduce the risk of major thrombotic vascular events in patients with symptomatic peripheral artery disease undergoing revascularisation

An international, multicentre, randomised, double-blind, placebo-controlled Phase III trial has commenced recruitment to investigate the efficacy and safety of rivaroxaban to reduce the risk of major thrombotic vascular events in patients with symptomatic peripheral artery disease undergoing lower extremity revascularization procedures. Target enrolment is 6500 patients. The purpose of study is to test whether rivaroxaban added to standard of care treatment, when compared to placebo, has the potential to reduce the incidence of the clinical events related to the clots and complications of the heart and brain (CV death, MI, or stroke) or the legs (acute limb ischemia or major amputation) in patients who had undergone recent procedure(s) to improve the blood flow in their legs.