Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease
Intervention: Rivaroxaban (Xarelto, BAY59-7939); Rivaroxaban-Placebo
Intervention description: 2.5 mg, twice daily, orally, tablet; matching placebo, twice daily, orally, tablet
Intervention MeSH terms: Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 6564.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Rivaroxaban; Xarelto; Aspirin; Acetylic salicylic acid; Anticoagulant; Peripheral artery disease; Peripheral arterial disease; Revascularization; Acute limb ischemia; Amputation; Cardiovascular events

Summary:

      The purpose of study was to test whether rivaroxaban added to standard of care treatment,
      when compared to placebo, had 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 of their legs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥50

          -  Documented moderate to severe symptomatic lower extremity atherosclerotic peripheral
             artery disease

          -  Technically successful peripheral revascularization distal to the external iliac
             artery for symptomatic PAD (Peripheral artery disease) within the last 10 days prior
             to randomization

        Exclusion Criteria:

          -  Patients undergoing revascularization for asymptomatic PAD or mild claudication
             without functional limitation of the index leg.

          -  Patients undergoing revascularization of the index leg to treat an asymptomatic or
             minimally symptomatic restenosis of a bypass graft or target lesion restenosis.

          -  Prior revascularization on the index leg within 10 days of the qualifying
             revascularization.

          -  Planned dual antiplatelet therapy (DAPT) use for the qualifying revascularization
             procedure of clopidogrel in addition to Acetylic salicylic acid (ASA) for >6 months
             after the qualifying revascularization procedure; it is strongly recommended that any
             course of clopidogrel is kept to the minimum necessary in accordance with local
             standard of care and international practice guidelines (typically 30 days, or up to 60
             days for some drug-coated products or devices) and is only allowed for up to 6 months
             for complex procedures or devices in the investigator's opinion that require longer
             use.

          -  Planned use of any additional antiplatelet agent other than clopidogrel and ASA after
             the qualifying revascularization procedure.