Comparing Rivaroxaban Plus Aspirin Versus Single Antiplatelet Therapy to Prevent Blood Clots After Lower Limb Revascularization Surgery

What this Trial Is About

Researchers are evaluating the incidence of venous thromboembolism VTE in patients with multiple health conditions undergoing complex lower limb revascularization surgeries. The study focuses on comparing the use of rivaroxaban combined with aspirin against single antiplatelet treatments for preventing VTE. This trial addresses the lack of consensus on using direct oral anticoagulants for extended VTE prevention in such patients. Participants will be randomly assigned to one of two groups one receiving rivaroxaban 2.5 mg twice daily plus aspirin 100 mg daily, and the other receiving standard single antiplatelet therapy clopidogrel followed by aspirin or aspirin alone depending on the procedure. Treatment will continue for three months, with visits every two weeks and a mandatory Doppler ultrasound at day 30 to assess outcomes. During the study, patients will keep a symptom diary and attend regular clinic visits for tests and checkups. Researchers will measure the occurrence of VTE and monitor safety outcomes at 30 days after surgery. The trial includes 200 participants undergoing either endovascular or open surgery, with ongoing monitoring to evaluate the effectiveness and safety of the treatments over the study period.

VTE Incidence After Rivaroxaban + Aspirin or SAPT After Lower-limb Revascularization