CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,124 enrolled
Drug / intervention
rivaroxaban 2.5 mg +7 moredrug
Likely dose
rivaroxaban 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/NCT01830543
NCT01830543Phase 3Completed

An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention

Janssen Scientific Affairs, LLC·interventional·Posted Apr 12, 2013·Updated Sep 19, 2017

In Brief

A Phase 3 clinical trial evaluating rivaroxaban 2.5 mg, rivaroxaban 15 mg, and 6 other interventions for Atrial Fibrillation and Percutaneous Coronary Intervention. Completed, enrolled 2,124 participants across 348 sites in 25 countries.

Detailed Summary

The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin (ASA) or clopidogrel (or prasugrel or ticagrelor).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Czechia, Denmark, France, Germany, Malaysia, Mexico, Netherlands, Poland, Romania, Russia, South Africa, South Korea, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsBayer

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 12, 2013
Enrollment StartMay 10, 2013
Primary CompletionJul 28, 2016
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 13.2 years ago

Interventions

rivaroxaban 2.5 mgdrug

One 2.5 mg tablet twice daily for up to twelve months

rivaroxaban 15 mgdrug

One 15 mg tablet once daily for up to twelve months

rivaroxaban 10 mgdrug

One 10 mg tablet once daily for up to twelve months

aspirin (ASA)drug

Low-dose aspirin tablet once daily for twelve months

vitamin K antagonist (VKA)drug

Dose-adjusted VKA tablet (target International Normalized Ratio (INR) 2.0 to 3.0) once daily for twelve months

clopidogreldrug

One 75 mg tablet once daily for up to twelve months

prasugreldrug

One 10 mg tablet once daily for up to twelve months

ticagrelordrug

One 90 mg tablet twice daily for up to twelve months