Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study

PHASE4UnknownINTERVENTIONAL
Enrollment

2,200

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

December 31, 2017

Study Completion Date

December 31, 2017

Conditions
Atrial Fibrillation
Interventions
DRUG

Rivaroxaban and single antiplatelet drug (aspirin, clopidogrel or prasugrel)

"* Rivaroxaban will be orally administered after a meal at a dose of 15 mg if the creatinine clearance (CLcr) is 50 mL/min or more and at a dose of 10 mg if the CLcr is 15-49 mL/min (regardless of time)~* Antiplatelet will be selected from aspirin or thienopyridine derivatives (clopidogrel or prasugrel)~ * Aspirin will be orally administered once a day at a dose of 81 mg or 100 mg~ * Clopidogrel will be orally administered once a day after a meal at a dose of 75 mg. The dose will be reduced to 50mg once a day depending on age, body weight or clinical findings.~ * Prasugrel will be orally administered once a day at a dose of 3.75 mg. If the body weight is 50kg or less a reduced dose(2.5 mg once a day) will be considered depending on the age, renal function or other bleeding and thrombotic risk."

DRUG

Rivaroxaban

Rivaroxaban will be orally administered at a dose of 15 mg if the creatinine clearance (CLcr) is 50 mL/min or more and at a dose of 10 mg if the CLcr is 15-49 mL/min.

Trial Locations (1)

565-8565

RECRUITING

Japan Cardiovascular Research Foundation, Suita

All Listed Sponsors
lead

Japan Cardiovascular Research Foundation

OTHER