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

Trial ID or NCT#

NCT02504216

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

An International, Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial Investigating 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

Eligibility Criteria

Ages Eligible for Study: Older than 50 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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.
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Investigator(s)

Nicholas Leeper
Nicholas Leeper
Cardiologist, Vascular medicine specialist
Professor of Surgery (Vascular Surgery) and of Medicine (Cardiovascular)

View on ClinicalTrials.gov