Evaluation of Effectiveness and Safety of Xa Inhibitor for the Prevention of Stroke And Systemic Embolism in a Nationwide Cohort of Japanese Patients Diagnosed as Non-valvular Atrial Fibrillation

Study Overview
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Brief Summary
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The efficacy and safety of a novel oral Xa inhibitor for stroke and systemic embolism, namely rivaroxaban, in non-valvular atrial fibrillation patients are evaluated in Japanese clinical practice.

Official Title
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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
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Non-valvular Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who meet all the criteria below Patients aged over 20 years Patients diagnosed with non-valvular atrial fibrillation Patients who are treated or will be treated with rivaroxaban Patients from whom written informed consent has been obtained Exclusion Criteria: Patients who meet any of the criteria below 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))

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-valvular atrial fibrillation<br>Patients diagnosed with non-valvular atrial fibrillation Patients who are treated or will be treated with rivaroxaban | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combinations of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism | Primary efficacy endpoint | up to March/2016 | 
| Clinically significant hemorrhagic events (massive hemorrhage in accordance with the ISTH classification) | Primary safety endpoint | up to March/2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combinations of symptomatic stroke (ischemic or hemorrhagic), systemic embolism, myocardial infarction and cardiovascular death | Secondary efficacy endpoints | up to March/2016 | 
| Symptomatic ischemic stroke | Secondary efficacy endpoints | up to March/2016 | 
| Symptomatic hemorrhagic stroke | Secondary efficacy endpoints | up to March/2016 | 
| Systemic embolism | Secondary efficacy endpoints | up to March/2016 | 
| Acute myocardial infarction/unstable angina pectoris | Secondary efficacy endpoints | up to March/2016 | 
| Cardiovascular death | Secondary efficacy endpoints | up to March/2016 | 
| Deep vein thrombosis/pulmonary thromboembolism | Secondary efficacy endpoints | up to March/2016 | 
| Transient ischemic attack | Secondary efficacy endpoints | up to March/2016 | 
| Interventional/surgical treatment | Secondary efficacy endpoints | up to March/2016 | 
| All-cause death | Secondary efficacy endpoints | up to March/2016 | 
| Clinically insignificant hemorrhagic events (hemorrhagic events other than clinically significant hemorrhagic events) | Secondary safety endpoint | up to March/2016 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rivaroxaban, NOAC, Non-valvular atrial fibrillation, Xa inhibitor