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 (VOYAGER PAD)

Bayer

Status and phase: Completed; Phase 3

Conditions: Peripheral Artery Disease

Treatments: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Rivaroxaban-Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02504216

2014-005569-58 (EudraCT Number)

17454

Details and patient eligibility

About

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.

Enrollment: 6,564 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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6,564 participants in 2 patient groups, including a placebo group

Rivaroxaban

Experimental group

Description:

Rivaroxaban 2.5 mg orally twice daily (5 mg cumulative daily dose)

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Placebo

Placebo Comparator group

Description:

Rivaroxaban-placebo orally twice daily

Treatment:

Drug: Rivaroxaban-Placebo