NCT01288352已完成4 期
Early Therapy of Atrial Fibrillation for Stroke Prevention Trial (EAST).
Atrial Fibrillation Network11 个研究点 分布在 11 个国家目标入组 2,789 人开始时间: 2011年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,789
- 试验地点
- 11
- 主要终点
- A composite of cardiovascular death, stroke and hospitalization due to worsening of heart failure or due to acute coronary syndrome.
研究概览
简要总结
EAST prospectively tests the hypothesis that an early, structured rhythm control therapy based on antiarrhythmic drugs and catheter ablation can prevent atrial fibrillation (AF) related complications in patients with AF when compared to usual care.
Patients will be randomized to early therapy or usual care. In the early therapy group, patients will receive either catheter ablation (usually by pulmonary vein isolation), or adequate antiarrhythmic drug therapy at an early time point. The initial therapy will be selected by the local investigator. Upon AF recurrence, both modalities will be combined.
Usual care will be conducted following the 2010European Society of Cardiology ( ESC )guidelines for AF treatment. Early rhythm control therapy will be guided by Electrocardiogram (ECG) monitoring.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent-onset AF (≤ 1 year prior to enrolment)
- •At least one ECG within recent 12 months that documents AF whereas the AF episode must last longer than 30 sec.
- •One of the following:
- •age > 75 years or
- •prior stroke or transient ischemic attack
- •OR two of the following:
- •age > 65 years,
- •female sex,
- •arterial hypertension (chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure > 145/90 mmHg),
- •diabetes mellitus (treated by drugs or insulin) or impaired glucose tolerance
- •severe coronary artery disease (previous myocardial infarction, CABG or PCI)
- •stable heart failure (NYHA II or LVEF <50%),
- •left ventricular hypertrophy on echocardiography (more than 15 mm wall thickness),
- •chronic kidney disease (MDRD stage III or IV),
- •peripheral artery disease.
- •Provision of signed informed consent.
- •Age ≥ 18 years.
排除标准
- •Any disease that limits life expectancy to less than 1 year.
- •Participation in another clinical trial, either within the past two months or ongoing
- •Previous participation in the EAST trial.
- •Pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception [oral contraception or intra-uterine device (IUD)] or sterile women can be randomized.
- •Breastfeeding women.
- •Drug abuse.
- •Prior AF ablation or surgical therapy of AF.
- •Previous therapy failure on amiodarone, e.g. patients who suffered from symptomatic recurrent AF that required escalation of therapy while on amiodarone.
- •Patients not suitable for rhythm control of AF.
- •Severe mitral valve stenosis.
- •Prosthetic mitral valve.
- •Clinically relevant hepatic dysfunction requiring specific therapy.
- •Clinically manifest thyroid dysfunction requiring therapy. After successful treatment of thyroid dysfunction, patients may be enrolled when their thyroid function is controlled.
- •Severe renal dysfunction (stage V, requiring or almost requiring dialysis).
结局指标
主要结局
A composite of cardiovascular death, stroke and hospitalization due to worsening of heart failure or due to acute coronary syndrome.
时间窗: 8 years
The 1st co-primary outcome parameter is defined as the time to the first occurrence of a composite of cardiovascular death, stroke / transient ischemic attack (TIA), and hospitalization due to worsening of heart failure or due to acute coronary syndrome. The second co-primary outcome is nights spent in hospital per year. The 2nd co-primary outcome is nights spent in hospital per year.
次要结局
- Key 2d outcomes: Each of the components of the 1st outcome, time to recurrent AF, cv hospitalizations, all-cause hospitalizations, left ventricular function, QL, cognitive function, cost of therapy.(8 years)
研究者
研究点 (11)
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