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



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:50 - Any
Updated:4/5/2019
Start Date:August 18, 2015
End Date:November 18, 2019

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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

The purpose of study is to test whether rivaroxaban added to standard of care treatment, when
compared to placebo, has 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.


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.
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