Status:
ACTIVE_NOT_RECRUITING
STroke Secondary Prevention With Catheter ABLation and EDoxaban for Patients With Non-valvular Atrial Fibrillation: STABLED Study
Lead Sponsor:
Nippon Medical School
Collaborating Sponsors:
Daiichi Sankyo Co., Ltd.
Conditions:
Ischemic Stroke
Atrial Fibrillation Non-Rheumatic
Eligibility:
All Genders
20-85 years
Phase:
PHASE3
Brief Summary
Catheter ablation (CA) has been reported to reduce risk of stroke in patients with nonvalvular atrial fibrillation (NVAF) in retrospective studies, but risk and benefit of CA has not been well elucida...
Detailed Description
In patients with NVAF, stroke is an independent risk factor for a subsequent cerebral infarction. Although anticoagulant therapy can effectively reduce thromboembolic events, the reported annual recur...
Eligibility Criteria
Inclusion
- Age ≥20 or ≤85 years at time of giving informed consent
- Nonvalvular atrial fibrillation
- History of stroke in previous 6 months
- Current or planned treatment with edoxaban
- Modified Rankin scale ≤3
Exclusion
- Symptomatic paroxysmal AF resistant to anti-arrhythmic drugs
- Presence of left atrial thrombus and left atrial appendage on transthoracic echocardiography, computed tomography or magnetic resonance imaging
- Unable to take anticoagulation therapy for any reason, including tendency to bleed or considered at high risk for bleeding from anticoagulation therapy.
- Presence of severe renal disorder (estimated creatinine clearance \<30 mL/min by Cockroft-Gault equation)
- Previous CA or surgical intervention for AF
- History of treatment with a left atrial appendage closure device
- Left atrial diameter ≥55 mm on transthoracic echocardiography
- Ejection fraction ≤35% on transthoracic echocardiography
- Persistent AF for ≥10 years
- Pregnant or possibility of pregnancy
- Unlikely to complete the study, such as due to progressive malignant tumor
- Participating or planning to participate in another clinical trial
- Unwilling to participates
- Judged as incompatible for the study by the investigators
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT03777631
Start Date
April 1 2018
End Date
March 31 2026
Last Update
November 15 2023
Active Locations (46)
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1
Ichinomiyanishi Hospital
Aichi, Japan
2
Hirosaki Stroke and Rehabilitation Center
Aomori, Japan
3
Hirosaki University Hospital
Aomori, Japan
4
Kimitsu Chuo Hospital
Chiba, Japan