drugset / Trial / NCT01674647

Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion

NCT01674647

Phase 3 Completed 1504 enrolled Bayer Janssen Research & Development, LLC · collab
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2012-10
Primary completion
2014-01
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluindione Small molecule Oral
Comparator Phenprocoumon Small molecule Oral
Subject Rivaroxaban Other / unclassified 15 mg Oral
Subject Rivaroxaban Other / unclassified 20 mg Oral
Comparator Warfarin Small molecule Oral
Comparator acenocoumarol Unknown Oral

Indications