Phase 3 Study Comparing REGN7508 and REGN9933 to Rivaroxaban and Placebo for Preventing Blood Clots After Leg Procedures in Adults with Peripheral Artery Disease

What this Trial Is About

Researchers are evaluating two experimental drugs, REGN7508 and REGN9933, for people with Peripheral Artery Disease PAD, a condition where blood vessels in the arms and legs become narrowed. The study focuses on individuals who have recently undergone Lower Extremity Revascularization LER, a procedure to improve blood flow in the legs and feet. The goal is to understand how well these drugs prevent serious blood clots compared to rivaroxaban and a placebo, while monitoring side effects and how the drugs affect blood clotting. Participants are randomly assigned to receive either REGN7508, REGN9933, rivaroxaban, or a placebo, with the treatments administered according to the study protocol. The study is designed as a Phase 3, multicenter, randomized trial with multiple groups running in parallel, and participants are followed for up to approximately 42 months. During this time, researchers will monitor drug levels in the blood, check for antibodies against the drugs, and evaluate the effects on blood clotting. Throughout the study, participants will have regular assessments to track the time to serious vascular events such as acute limb ischemia, major amputations, heart attacks, strokes, and cardiovascular death. Safety is closely watched by recording any bleeding events and adverse effects. Laboratory tests will measure blood clotting times and antibody levels up to about 45 months. The total participation duration may last around 3.5 years, with ongoing monitoring to evaluate treatment effects and safety.

Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease