Non-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.)
Conditions
Interventions
None listed
Sponsors
Fukui Red Cross Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all the criteria below 1) Patients aged over 20 years 2) Patients diagnosed with non-valvular atrial fibrillation 3) Patients have newly anticoagulation planned with rivaroxaban 4) Patients from whom written informed consent has been obtained 5) Patients have availability for follow-up as outpatient visit(PS3<=)
Exclusion criteria
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>)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The assessment with Quality of Life(QOL) The examination of coagulation/fibrinolysis status and vascular function | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactToshinari Tsubokawa
Fukui Red Cross Hospital Cardiology
Outcome results
None listed