Multicenter study associated with KYU-shu to evaluate the efficacy and safety of edoxaban in patients with non-valvulaR Atrial fiBriLlation undergoing cathEter ablation.
Not Applicable
- Conditions
- patients with non-valvular atrial fibrillation
- Registration Number
- JPRN-UMIN000029693
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 541
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Combination of thromboembolic events (Stroke / systemic embolism) and major bleeding for 4 weeks from the date of catheter ablation.
- Secondary Outcome Measures
Name Time Method 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.