CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 6,564 enrolled
Drug / intervention
Rivaroxaban (Xarelto, BAY59-7939) +1 moredrug
Likely dose
Rivaroxaban (Xarelto, BAY59-7939) 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02504216
NCT02504216Phase 3Completed
CompareCT.gov

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

Bayer·interventional·Posted Jul 21, 2015·Updated Dec 8, 2020

In Brief

A Phase 3 clinical trial evaluating Rivaroxaban (Xarelto, BAY59-7939) and Rivaroxaban-Placebo for Peripheral Artery Disease. Completed, enrolled 6,564 participants across 532 sites in 34 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Artery Disease
CountriesArgentina, 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, United States
CollaboratorsJanssen Research & Development, LLC, Colorado Prevention Center

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 21, 2015
Enrollment StartAug 18, 2015
Primary CompletionNov 27, 2019
Study CompletionJan 9, 2020
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 10.9 years ago

Interventions

Rivaroxaban (Xarelto, BAY59-7939)drug

2.5 mg, twice daily, orally, tablet

Rivaroxaban-Placebodrug

matching placebo, twice daily, orally, tablet