CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,280 enrolled
Drug / intervention
Rivaroxaban (Xarelto, BAY59-7939) +3 moredrug
Likely dose
Rivaroxaban (Xarelto, BAY59-7939) 15 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/NCT00494871
NCT00494871Phase 3Completed
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Evaluation of the Efficacy and Safety of Rivaroxaban (BAY59-7939) for the Prevention of Stroke and Non-central Nervous System Systemic Embolism in Subjects With Non-valvular Atrial Fibrillation

Bayer·interventional·Posted Jul 2, 2007·Updated Apr 20, 2015

In Brief

A Phase 3 clinical trial evaluating Rivaroxaban (Xarelto, BAY59-7939), Warfarin, and 2 other interventions for Atrial Fibrillation. Completed, enrolled 1,280 participants across 165 sites.

Detailed Summary

This is a clinical study evaluating the efficacy and safety of rivaroxaban for stroke prevention in patients with atrial fibrillation (originally described in Japanese).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesJapan
CollaboratorsJanssen R&D, L.L.C.

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2, 2007
Enrollment StartJun 1, 2007
Primary CompletionDec 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 19 years ago

Interventions

Rivaroxaban (Xarelto, BAY59-7939)drug

Participants orally administered rivaroxaban 15 mg OD (CrCL \[creatinine clearance\] \>= 50 mL/min) or 10 mg OD (CrCL 30-49 mL/min)

Warfarindrug

Participants orally administered a warfarin potassium tablet (INR \[international normalized ratio\] target was 1.6-2.6 for patients \>70 years and 2.0-3.0 for patients \<70 years)

Rivaroxaban placebodrug

Participants orally administered a rivaroxaban placebo tablet

Warfarin placebodrug

Participants orally administered a warfarin placebo tablet (adjusted based upon sham INR values)