STroke Secondary Prevention With Catheter ABLation and EDoxaban for Patients With Non-valvular Atrial Fibrillation: STABLED Study
- Conditions
- Ischemic StrokeAtrial Fibrillation Non-Rheumatic
- Registration Number
- NCT03777631
- Lead Sponsor
- Nippon Medical School
- 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 elucidated in NVAF with recent cerebral infarction in prospective randomized trials.
- 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 recurrence rate in NVAF and previous stroke patients in the "real-world" is not low even with appropriate antithrombotic treatment; 8.6% in patients with "guideline adherent" antithrombotic therapy and around 5% in patients treated with anticoagulant therapy. NVAF and recent stroke is high-risk population for stroke recurrence even with anticoagulant therapy, and developing optimal secondary prevention strategy is an urgent task.
Catheter ablation (CA) is now widely used to treat symptoms related to NVAF. Some retrospective studies showed a beneficial effect of CA for stroke prevention using age-/sex-matching or propensity-score matching. Moreover, CA have a potential to improve survival or prevent heart failure development in patients with AF. However, the effect of CA for secondary stroke prevention or impact of CA for NVAF patients with recent ischemic stroke for survival or developing heart failure has not been evaluated in a prospective randomized trial. Therefore, in the present study, we intend to compare two groups of patients with NVAF with a history of cerebral infarction: a group receiving standard medical therapy (control group) and a group receiving standard medical therapy plus CA (CA group).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 251
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Composite of recurrence of cerebral infarction, systemic embolism, all-cause death, hospitalization for heart failure. Up to 6 years Composite of recurrence of cerebral infarction, systemic embolism, all-cause death, hospitalization for heart failure.
- Secondary Outcome Measures
Name Time Method Recurrence of cerebral infarction in patients with or without discontinuation of Edoxaban Up to 6 years Recurrence of cerebral infarction in patients with or without discontinuation of Edoxaban
Any bleeding Up to 6 years Any bleeding
Hospitalization for heart failure Up to 6 years Hospitalization for heart failure
Recurrence of cerebral infarction Up to 6 years Recurrence of cerebral infarction
All-cause death Up to 6 years All-cause death
Cardiovascular death Up to 6 years Cardiovascular death
Intracranial hemorrhage Up to 6 years Intracranial hemorrhage
Composite events Up to 6 years all-cause death, onset of stroke, systemic embolism, hospitalization for heart failure, and serious adverse event caused by CA
The rate of and related factors to discontinuation of Edoxaban Up to 6 years The rate of and related factors to discontinuation of Edoxaban
Systemic embolism Up to 6 years Symptomatic systemic embolism to other regions than brain, e.g. peripheral or visceral arteries
Trial Locations
- Locations (46)
Ichinomiyanishi Hospital
🇯🇵Aichi, Japan
Hirosaki Stroke and Rehabilitation Center
🇯🇵Aomori, Japan
Hirosaki University Hospital
🇯🇵Aomori, Japan
Kimitsu Chuo Hospital
🇯🇵Chiba, Japan
New Tokyo Heart Clinic
🇯🇵Chiba, Japan
New Tokyo Hospital
🇯🇵Chiba, Japan
Nippon Medical School Chiba Hokusoh Hospital
🇯🇵Chiba, Japan
Kokura Memorial Hospital
🇯🇵Fukuoka, Japan
National Hospital Organization Kyushu Medical Center
🇯🇵Fukuoka, Japan
Ogaki Municipal Hospital
🇯🇵Gifu, Japan
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