patients with non-valvular atrial fibrillation
Conditions
Interventions
Method for administration of Edoxaban Until the day before catheter ablation : Oral administration for 4 weeks or more is performed every morning. The day of catheter ablation : After the ablation,
Sponsors
DAIICHI SANKYO CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient definitively diagnosed as non-valvular atrial fibrillation. 2) Patients scheduled to undergo catheter ablation for non-valvular atrial fibrillation. 3) Patients who have given informed consent in writing from oneself.( 20 years of age or older)
Exclusion criteria
Exclusion criteria: (1) Patients falling under the administration contraindication for non-valvular atrial fibrillation of Edoxaban formulation. (2) Patients who are creatinine clearance <30 mL/min. (3) Patients contraindicated to undergo catheter ablation. (4) Patients who developed thromboembolism or myocardial infarction within 2 months before registration. (5) Patients who can't interrupt administration of antiplatelet drugs one week before catheter ablation is performed. (6) Patients of CHADS2 score is 6 points. Such as 18 items.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combination of thromboembolic events (Stroke / systemic embolism) and major bleeding for 4 weeks from the date of catheter ablation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The following expression rate events for 4 weeks from the date of by catheter ablation. -All death -Stroke / systemic embolism -Major bleeding -Clinically relevant non major bleeding -Minor bleeding -Cardiovascular events -All adverse events 2) The variation of thrombotic / thrombolytic biomarkers by catheter ablation perioperative period. | — |
Countries
Japan
Contacts
Public ContactTetsuya Maejima
DAIICHI SANKYO RD NOVARE CO., LTD. Clinical Development Group3 Clinical Development Department
Outcome results
None listed