Non-valvular atrial fibrillation
Conditions
Interventions
Rivaroxaban monotherapy 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 until end
Sponsors
Japan Cardiovascular Research Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with non-valvular atrial fibrillation complicated with stable coronary artery disease who are 20 years or more at the obtaining of informed consent, CHADS2 score are 1 or more, and fulfil the criteria below and can provide written consent for participation in the present study will be eligible. 1) Patients who underwent percutaneous coronary intervention, including plain old balloon angioplasty, at least one year ago 2) Patients who have coronary stenosis requiring no percutaneous coronary intervention (50% or more stenosis) as indicated by coronary CT or coronary angiography 3) Patients who underwent coronary artery bypass graft CABG at least one year ago
Exclusion criteria
Exclusion criteria: 1)Patients who are contraindicated for rivaroxaban 2)Patients who are contraindicated for aspirin, thienopyridine derivatives (clopidogrel or prasugrel) 3)Patients who underwent PCI, including POBA, in the past one year 4)Patients who are going to undergo revascularization 5)Patients who have a past history of stent thrombosis 6)Those who are going to undergo invasive surgery (excluding digestive endoscopy and biopsy) 7)Patients who have active tumors 8)Patients who have poorly-controlled hypertension (systolic blood pressure at hospital admission based on two or more measurements: 160 mmHg or more) 9)Patients who cannot discontinue treatment with antiplatelet drugs (the physician in charge will make a decision on the basis of the lesion shape, lesion site and type of stents.) (10)Patients judged as inappropriate for this study by investigators Contraindicated for rivaroxaban (1)Unstable CAD (2)Patients with a past history of stent thrombosis (3)Patients judged as inappropriate for this study by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1)Primary efficacy endpoints Composite endpoint of cardiovascular events (stroke, non-CNS embolism, myocardial infarction, unstable angina pectoris requiring revascularizations or all-cause mortality) (2)Safety primary endpoints Major bleeding defined by the International Society on Thrombosis and Haemostasis (ISTH) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Net adverse clinical and cerebral events (NACCE) (net clinical benefit) All-cause death, myocardial infarction, stroke and major bleeding 2)Ischemic cardiovascular events and death (1)All-cause mortality (2)Cardiovascular death (3)Non-cardiovascular death (4)Myocardial infarction (5)Unstable angina pectoris requiring revascularization (6)Ischemic stroke (7)Transient ischemic attack (8)Systemic embolism (9)PCI/CABG (10)Stent thrombosis (11)Ischemic stroke and systemic embolism 3)Any bleeding 4)Adverse events excluding hemorrhagic events 5)Comparison of the primary endpoints between patients treated with aspirin and treated with thienopyridine derivatives 6)Stratified analysis of the primary endpoints, ischemic cardiovascular events and mortality according to the CHADS2 score and CHA2DS2-VASc score 7)Stratified analysis of the incidences of the primary endpoints, ischemic cardiovascular events and mortality according to subject characteristics 8)Stratified analysis of major bleeding and all bleeding events in patients treated concomitantly with any antiplatelet and patients not treated with any antiplatelet according to the HAS-BLED score and analysis of specificity and sensitivity 9)Comparison of the incidence of bleeding events according to whether or not proton pump inhibitors (PPIs) are used 10)Comparison of the incidences of the primary endpoints according to whether rivaroxaban is administered in the morning or evening 11)Investigation of relationships between ischemic cardiovascular events, bleeding events/adverse events and discontinuation of treatment with antithrombotic agents 12)Investigation of relationships between prothrombin time at trough and bleeding events and the cutoff values according to whether or not antiplatelet drugs are concomitantly used 13)The incidence of the primary endpoints according to adherence | — |
Countries
Japan
Contacts
Public ContactSaburo Saito
Japan Cardiovascular Research Foundation Administration Office
Outcome results
None listed