Phase 3
Completed N=1,280
Efficacy and Safety of Rivaroxaban for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation
Source: ClinicalTrials.gov NCT00494871 ↗Enrolled (actual)
1,280
Serious AEs
15.5%
Results posted
Apr 2012
Primary outcomePrimary: Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding — 18.04; 16.42 Events per 100 patient-years — p=0.025
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding |
18.04; 16.42 | 0.025 sig |
| SECONDARY Event Rate of the Composite Endpoint of Adjudicated Stroke and Non-central Nervous System (CNS) Systemic Embolism |
1.26; 2.61 | — |
| SECONDARY Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, and Vascular Death |
1.83; 2.85 | — |
| SECONDARY Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, Myocardial Infarction, and Vascular Death |
2.18; 2.97 | — |
| SECONDARY Event Rate of Stroke |
1.15; 2.49 | — |
| SECONDARY Event Rate of Non-CNS Systemic Embolism |
0.11; 0.12 | — |
| SECONDARY Event Rate of Myocardial Infarction |
0.34; 0.12 | — |
| SECONDARY Event Rate of Vascular Death |
0.69; 0.24 | — |
| SECONDARY Event Rate of Stroke With Serious Residual Disability |
0.57; 1.19 | — |
| SECONDARY Event Rate of All-cause Death |
0.80; 0.59 | — |
| SECONDARY Event Rate of Adjudicated Major Bleeding |
3.00; 3.59 | — |
| SECONDARY Event Rate Adjudicated Non-major Clinically Relevant Bleeding |
15.42; 12.99 | — |
Eligibility Criteria
Inclusion Criteria
- 20 years or older
- Japanese male or female
- Non- valvular atrial fibrillation documented by ECG
- Patients with a risk of stroke and non-CNS systemic embolism
Exclusion Criteria
- Significant mitral stenosis
- Patients in whom anticoagulants are contraindicated
Data sourced from ClinicalTrials.gov (NCT00494871). 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. Informational only — not medical advice.