non-valvular atrial fibrillation
Conditions
Interventions
Standard medication Group: Anticoagulation therapy should be Edoxaban. In addition, antiarrhythmic drugs are appropriately administered depending on the condition. Dosage is according to the pack
Sponsors
Nippon Medical School Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 20<=, 80> aged patients at the time of obtaining the informed consent 2) Patients with non-valvular atrial fibrillation 3) have a history of a prior stroke within 6 months before enrolment 4) Patients who is being treated or will be treated with Edoxaban 5) Patients with modified Rankin Scale under 3
Exclusion criteria
Exclusion criteria: 1) Patients who have symptomatic paroxysmal atrial fibrillation and drug resistant 2) Patients who have Left Atrial Thrombus and left atrial appendage by transthoracic echocardiography, Computed Tomography(CT),Magnetic Resonance Imaging(MRI) 3) Patients who have a tendency to bleed or bleed and are considered to be at high risk of bleeding due to anticoagulation therapy. For other reasons, patients who cannot conduct anticoagulation therapy 4) Patients who are suffering from severe renal disorder (Ccr*<30mL/min) *Cockroft-Gault Equation 5) Patients who have undergone catheter ablation or surgical intervention for AF 6) Patients who have a treatment history with left atrial appendage closure device 7) Patients who have a left atrial diameter;55mm<= with transthoracic echocardiography 8) Patients who have ejection fraction;35%>= with transthoracic echocardiography 9) Persistent non-valvular atrial fibrillation over 10 years 10)Patients who have atrial septal defect 11) Patients who are pregnant and of child-bearing potential 12) Patients who are unlikely to complete research, such as progressive malignant tumor 13) Patients who is being participated or will be participated to other clinical trials 14) Patients who do not agree the study inclusion 15) Patients judged as inappropriate for this study by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following composite events during observation period 1: Recurrence of ischemic stroke 2: Systemic embolism 3: All cause death 4: Hospitalization by Heart Failure | — |
Secondary
| Measure | Time frame |
|---|---|
| <<Secondary Endpoints>> 1: Onset of stroke 2: Recurrence of ischemic stroke 3: Systemic embolism 4: All cause death 5: Cardiovascular death 6: Hospitalization by Heart Failure 7: Any bleeding 8: Onset of intracranial hemorrhage 9: Composite events (all cause death, onset of stroke, systemic embolism, hospitalization by Heart Failure, serious adverse event caused by catheter ablation) <<The other Endpoints>> 1: Modified Rankin scale score and NYHA classification at the end of observation period 2: Maintenance rate of sinus rhythm 3: Changes in Mini-Mental State Examination (MMSE) scores during observation period 4: The continuation rate of Edoxaban 5: Recurrence rate of stroke according to whether or not Edoxaban discontinue 6: Factors which contribute to discontinue Edoxaban | — |
Countries
Japan
Contacts
Public ContactKaoru Okabe
EP-CRSU Co.,Ltd Clinical Research Headquaters, Management Department 2 Section1
Outcome results
None listed