NCT02504216

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,564 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DRUG	Rivaroxaban (Xarelto, BAY59-7939)	2.5 mg, twice daily, orally, tablet
DRUG	Rivaroxaban-Placebo	matching placebo, twice daily, orally, tablet

Timeline

• Start date: 2015-08-18
• Primary completion: 2019-11-27
• Completion: 2020-01-09
• First posted: 2015-07-21
• Last updated: 2020-12-08
• Results posted: 2020-12-08

Locations

532 sites across 34 countries: United States, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Estonia, Finland, France, Germany, Hungary, Italy, Japan, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study