Prospective and Non-interventional registry to Investigate Effectiveness and Safety of Rivaroxaban on Prevention of Stroke and Systemic Embolism in Patients with Non-valvular Atrial Fibrillation at Fukui Red Cross Hospital

Not Applicable

Recruiting

• 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-UMIN000017523
• Lead Sponsor: Fukui Red Cross Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-12
• Study Completion: 2015-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

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)) -Patients with acute bacterial endocarditis - Patients have remaining effects are received with other anticoagulation therapy -Patients are unstable state of blood pressure(18/120mmHg>)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The assessment with Quality of Life(QOL) The examination of coagulation/fibrinolysis status and vascular function

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)