Multi-center, Prospective, Non-interventional, Observational Cohort Study to Investigate Effectiveness and Safety of Rivaroxaban on Prevention of Stroke and Systemic Embolism in Patients with Non-valvular Atrial Fibrillation in Japanese Clinical Practice
- Conditions
- on-valvular atrial fibrillation (In the present study, non-valvular atrial fibrillation refers to atrial fibrillation without a history of prosthetic valve replacement or mitral valve stenosis.)
- Registration Number
- JPRN-UMIN000009376
- Lead Sponsor
- Tohoku University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 7000
Not provided
The following patients in whom rivaroxaban is contraindicated for use - Patients with a history of allergies to the ingredients contained in this drug - Patients having a hemorrhagic event (intracranial hemorrhage, gastrointestinal hemorrhage or other clinically significant hemorrhagic events) - Patients having liver disease complicated with coagulation disorder or those having moderate or worse liver disorder (Grade B or C in accordance with the Child-Pugh classification) - Patients having renal failure (creatinine clearance: <15 mL/min) - Women who are or are likely to be pregnant - Patients who are treated with HIV protease inhibitors (including ritonavir, atazanavir and indinavir) - Patients who are treated with oral or injectable formulations of azole antifungal drugs (including itraconazole, voriconazole and ketoconazole (excluding fluconazole))
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy endpoint - Combinations of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism Primary safety endpoint - Clinically significant hemorrhagic events (massive hemorrhage in accordance with the ISTH classification)
- Secondary Outcome Measures
Name Time Method Secondary efficacy endpoints - Combinations of symptomatic stroke (ischemic or hemorrhagic), systemic embolism, myocardial infarction and cardiovascular death - Symptomatic ischemic stroke - Symptomatic hemorrhagic stroke - Systemic embolism - Acute myocardial infarction/unstable angina pectoris - Cardiovascular death - Deep vein thrombosis/pulmonary thromboembolism - Transient ischemic attack - Interventional/surgical treatment - All-cause death Secondary safety endpoint - Clinically insignificant hemorrhagic events (hemorrhagic events other than clinically significant hemorrhagic events)