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

• Conditions: Non-valvular Atrial Fibrillation

• Registration Number: NCT02147444
• Lead Sponsor: Tohoku University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Status Verified: 2014-05
• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-21
• Last Update Submitted: 2014-05-21
• Study First Posted: 2014-05-26
• Last Update Posted: 2014-05-26
• Primary Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 7000

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))

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine; 🇯🇵 Sendai, Miyagi, Japan