STroke Secondary Prevention With Catheter ABLation and EDoxaban for Patients With Non-valvular Atrial Fibrillation: STABLED Study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 251
- 试验地点
- 46
- 主要终点
- Composite of recurrence of cerebral infarction, systemic embolism, all-cause death, hospitalization for heart failure.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Composite of recurrence of cerebral infarction, systemic embolism, all-cause death, hospitalization for heart failure.
时间窗: Up to 6 years
Composite of recurrence of cerebral infarction, systemic embolism, all-cause death, hospitalization for heart failure.
次要结局
- Recurrence of cerebral infarction in patients with or without discontinuation of Edoxaban(Up to 6 years)
- Any bleeding(Up to 6 years)
- Hospitalization for heart failure(Up to 6 years)
- Recurrence of cerebral infarction(Up to 6 years)
- All-cause death(Up to 6 years)
- Cardiovascular death(Up to 6 years)
- Intracranial hemorrhage(Up to 6 years)
- Composite events(Up to 6 years)
- The rate of and related factors to discontinuation of Edoxaban(Up to 6 years)
- Systemic embolism(Up to 6 years)
研究者
Kazumi Kimura
Professor
Nippon Medical School