Voyager PAD

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

Voyager PAD [NCT02504216]

Description:  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.

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

Primary Investigator: Reginelli

Drug/Device Information
Investigating the efficacy and safety of Rivaroxaban to reduce the risk of major thrombotic vascular events in patients with symptomatic PAD undergoing lower extremity revascularization procedures
Randomized in a ratio of 1:1 to one of the 2 following treatment arms: Rivaroxaban 2.5 mg bid + ASA 100 mg once daily or Rivaroxaban-matching placebo bid + ASA 100 mg once daily
Bayer HealthCare AG