Conditions: Atrial Fibrillation
Keywords: BAY59-7939 Rivaroxaban Non-Valvular Atrial Fibrillation Japanese Patients Phase III 12620
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1280
Healthy volunteers: no

Brief 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).

Detailed description:
Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor.

Arms:
arm 1: Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period arm 2: Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period

Interventions: intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Warfarin intervention 3: Rivaroxaban placebo intervention 4: Warfarin placebo
Intervention descriptions: intervention 1: Participants orally administered rivaroxaban 15 mg OD (CrCL \[creatinine clearance\] \>= 50 mL/min) or 10 mg OD (CrCL 30-49 mL/min) intervention 2: Participants orally administered a warfarin potassium tablet (INR \[international normalized ratio\] target was 1.6-2.6 for patients \>70 years and 2.0-3.0 for patients \<70 years) intervention 3: Participants orally administered a rivaroxaban placebo tablet intervention 4: Participants orally administered a warfarin placebo tablet (adjusted based upon sham INR values)

Protocol document: