Vascular Outcomes Study of ASA Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease (PAD)

Principal Investigator: Joseph Mills, M.D.

Sponsored by:  Bayer Healthcare Pharmaceuticals

This international, multicenter, randomized, double-blind placebo controlled study will evaluate whether rivaroxaban added to acetylsalicylic acid (ASA) is superior to ASA alone in reducing the risk of major thrombotic vascular events in symptomatic PAD patients undergoing lower extremity revascularization procedure.

Main Inclusion Criteria: 

• Male or female over age 50 with symptomatic PAD with ischemic rest pain or ischemic ulceration
• Anatomical imaging evidence of arterial occlusive disease below the inguinal ligament within 6 months prior to or at the time of the qualifying revascularization

Exclusion Criteria:

• Patients undergoing revascularization for asymptomatic PAD or mild claudication without functional limitation of the index leg
• Planned dual antiplatelet therapy (DAPT) use for the qualifying revascularization procedure of clopidogrel in addition to ASA for >30 days after the qualifying revascularization procedure


Shawn Randle Shawn.Randle@bcm.eduPhone 1: (713) 798-3023
IRB: h-37075




May 13, 2016