CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,504 enrolled
Drug / intervention
Rivaroxaban (Xarelto, BAY59-7939) +1 moredrug
Likely dose
Rivaroxaban (Xarelto, BAY59-7939) 20 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/NCT01674647
NCT01674647Phase 3Completed
CompareCT.gov

A Prospective, Randomized, Open-label, Parallel-group, Active-controlled, Multicenter Study Exploring the Efficacy and Safety of Once-daily Oral Rivaroxaban (BAY59-7939) Compared With That of Dose-adjusted Oral Vitamin K Antagonists (VKA) for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion

Bayer·interventional·Posted Aug 29, 2012·Updated Apr 30, 2015

In Brief

A Phase 3 clinical trial evaluating Rivaroxaban (Xarelto, BAY59-7939) and Vitamin K antagonist (VKA) for Atrial Fibrillation. Completed, enrolled 1,504 participants across 178 sites in 17 countries.

Detailed Summary

A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm). The study will compare patients assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist (VKA). The study will measure common medical outcomes for this type of patient such as bleeding and stroke.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesBelgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Portugal, Singapore, South Africa, Spain, United Kingdom, United States
CollaboratorsJanssen Research & Development, LLC

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 29, 2012
Enrollment StartOct 1, 2012
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.8 years ago

Interventions

Rivaroxaban (Xarelto, BAY59-7939)drug

Rivaroxaban 20 mg orally once daily; subjects with moderate renal impairment (ie, CrCl of 30 to 49 mL/min, inclusive) will receive the adjusted dose of 15 mg orally once daily in the study

Vitamin K antagonist (VKA)drug

VKA orally once daily titrated to a target international normalized ratio (INR) of 2.5 (range 2.0-3.0, inclusive); the VKA type (eg, warfarin, acenocoumarol, phenprocoumon, fluindione, etc) will be assigned by the investigator according to local treatment standards