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

Bayer

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Warfarin placebo; Drug: Rivaroxaban placebo; Drug: Warfarin

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00494871

12620

Details and patient eligibility

About

This is a clinical study evaluating the efficacy and safety of rivaroxaban for stroke prevention in patients with atrial fibrillation (originally described in Japanese).

Full description

Within the US 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.' is sponsor.

Enrollment: 1,280 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,280 participants in 2 patient groups

Rivaroxaban (Xarelto, BAY59-7939)

Experimental group

Description:

Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period

Treatment:

Drug: Warfarin placebo

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Warfarin

Active Comparator group

Description:

Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period

Treatment:

Drug: Rivaroxaban placebo

Drug: Warfarin