Phase 3 N=1,280 Randomized Triple-blind Prevention

Efficacy and Safety of Rivaroxaban for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT00494871 ↗

Enrolled (actual)

1,280

Serious AEs

15.5%

Results posted

Apr 2012

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Rivaroxaban (Xarelto, BAY59-7939) (Drug); Warfarin (Drug); Rivaroxaban placebo (Drug); Warfarin placebo (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Bayer
Primary completion: Dec 2009

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	—

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).

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

View full record on ClinicalTrials.gov →

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.