CompletedPhase 3ACTRN12607000214437

A study comparing the efficacy and safety of once-daily oral rivaroxaban with warfarin for the prevention of stroke and embolism in patients with atrial fibrillation.

A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation

Sponsor

Bayer Australia Limited

Enrollment

14,269 participants

Start Date

Dec 14, 2006

Study Type

Interventional

Conditions

Stroke Non-central nervous system systemic embolism in subjects with non-valvular atrial fibrillation.

Summary

The purpose of this study is to demonstrate that the efficacy and safety of 20 mg once daily rivaroxaban in preventing thromboembolic events in subjects with atrial fibrillation not related to mitral valve stenosis. Subjects with moderate renal impairment at screening (defined as calculated creatinine clearance between 30 and 49 ml/min inclusive) will receive a dose adaptation to rivaroxaban 15 mg once daily.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares the effectiveness and safety of a once-daily oral medication against other treatment options. This study is open to both men and women aged 18 and older. Participation involves taking the assigned medication daily and attending regular check-ups for monitoring.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

This study is comparing the efficacy and safety of rivaroxaban with warfarin for the prevention of stroke and non-central nervous system systemic embolism in subjects with non-valvular atrial fibrillation. Those subjects assigned to rivaroxaban will receive rivaroxaban 20 mg orally once daily, plus warfarin placebo titrated to a sham International Normalised Ratio. Subjects with moderate renal impairment at screening (defined as calculated creatinine clearance between 30 and 49 ml/min inclusive) will receive a dose adaptation to rivaroxaban 15 mg once daily. The duration of the treatment period for a given subject will depend on the time required to accrue the required number of adjudicated primary efficacy endpoint events. As a result, the time on study drug will vary from subject to subject, however the expected maximum duration of the study is 32 months, but may extend to 4 years.