CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 14,269 enrolled
Drug / intervention
Rivaroxaban +3 moredrug
Likely dose
Rivaroxaban 20 mg orally once daily (or 15 mg daily in patients with moderate renal impairment)AI-extracted
Key inclusion· 2
  • ✓Documented atrial fibrillation on 2 separate occasions within 6 months before screening
  • ✓Prior stroke, TIA, or cardiac-origin non-neurologic systemic embolism, OR at least 2 of the following: heart failure, hypertension, age ≥75 years, diabetes mellitus
Key exclusion· 6
  • ✕Significant mitral stenosis
  • ✕Transient atrial fibrillation caused by a reversible disorder
  • ✕Active internal bleeding
  • ✕Severe disabling stroke

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00403767
NCT00403767Phase 3Completed
CompareCT.gov

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

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Nov 27, 2006·Updated Apr 29, 2014

In Brief

A Phase 3 clinical trial evaluating Rivaroxaban, Warfarin, and 2 other interventions for Atrial Fibrillation and 2 related conditions. Completed, enrolled 14,269 participants across 932 sites in 44 countries.

Detailed Summary

The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular atrial fibrillation (a heart rhythm disorder).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Stroke, Embolism
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Romania, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States, Venezuela
CollaboratorsBayer

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 27, 2006
Enrollment StartDec 1, 2006
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 19.6 years ago

Interventions

Rivaroxabandrug

Type=exact number, unit=mg, number=20, form=tablet, route=oral use. One 20 mg tablet once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years (Patients with moderate renal impairment at screening willl have a dose adaptation to rivaroxaban 15 mg, orally, once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years)

Warfarindrug

Type=exact number, unit=mg, number=1, 2.5, or 5 mg, form=tablet, route=oral use. Number of warfarin tablets to be determined based on target INR values once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years

Matching placebo for Rivaroxaban arm (Warfarin placebo)drug

Form=tablet, route=oral. One warfarin placebo tablet taken orally once daily for up to an expected maximum treatment period of 32 months that may extend up to 4 years

Matching placebo for Warfarin arm (Rivaroxaban placebo)drug

Form-tablet, Route=oral administration. Number of rivaroxaban placebo determined by the number of warfarin tablets taken. Duration of treatment is up to an expected maximum treatment period of 32 months that may extend up to 4 years