Phase 3
N=14,236
An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation
Atrial Fibrillation · Stroke · Embolism
Bottom Line
View on ClinicalTrials.gov: NCT00403767 ↗Enrolled (actual)
14,236
Serious AEs
37.7%
Results posted
Jul 2012
Primary outcome: Primary: The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority) — 188; 241 Patients — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rivaroxaban (Drug); Warfarin (Drug); Matching placebo for Rivaroxaban arm (Warfarin placebo) (Drug); Matching placebo for Warfarin arm (Rivaroxaban placebo) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority) |
188; 241 | <0.001 sig |
| PRIMARY The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority) |
189; 243 | 0.015 sig |
| PRIMARY The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety |
1475; 1449 | 0.442 |
| SECONDARY The Composite Event of Stroke/Non-CNS Systemic Embolism/Vascular Death |
346; 410 | 0.034 sig |
| SECONDARY The Composite Event of Stroke/Non-CNS Systemic Embolism/Myocardial Infarction/Vascular Death |
433; 519 | 0.010 sig |
| SECONDARY The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Stroke |
184; 221 | 0.092 |
| SECONDARY The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Non-CNS Systemic Embolism |
5; 22 | 0.003 sig |
| SECONDARY The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Myocardial Infarction |
101; 126 | 0.121 |
| SECONDARY The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Vascular Death |
170; 193 | 0.289 |
| SECONDARY All-cause Mortality |
208; 250 | 0.073 |
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).
Eligibility Criteria
Inclusion Criteria
- Patients must have documented atrial fibrillation on 2 separate occasions within 6 months before screening
- History of a prior stroke, transient ischemic attack or non-neurologic systemic embolism believed to be cardiac in origin, or at least two of the following risk factors: heart failure, hypertension, age 75 years or greater, diabetes mellitus
Exclusion Criteria
- Significant mitral stenosis
- Transient atrial fibrillation caused by a reversible disorder
- Active internal bleeding
- Severe disabling stroke
- History of intracranial bleeding
- Hemorrhagic disorders
Data sourced from ClinicalTrials.gov (NCT00403767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.