EURopean Trial In Atrial Fibrillation or Flutter Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 615
- 试验地点
- 2
- 主要终点
- The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence
研究概览
简要总结
To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL).
To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms.
To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF/AFL recurrence.
详细描述
This is a double-blind, parallel arm, placebo-controlled, multicentre, multinational, phase III study.
To be eligible, patients must be in normal sinus rhythm at randomisation and must have an ECG-documented history of recent AF/AFL reverted to normal sinus rhythm by electrical, pharmacological or spontaneous conversion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex aged 21 years or more, in sinus rhythm for at least 1 hour at the time of randomization and with at least one ECG-documented AF/AFL episode in the last 3 months.
排除标准
- •MAIN CRITERIA (non-exhaustive list, see protocol for details):
- •Women of childbearing potential without adequate birth control, Pregnant women, Breastfeeding women, Congestive heart failure NYHA class III or IV, Conditions which increase the risk of severe antiarrhythmic drug side effects, Severe associated conditions.
研究组 & 干预措施
Dronedarone 400mg bid
dronedarone 400mg tablets
干预措施: Dronedarone (SR33589) (Drug)
Placebo
matching placebo tablets
干预措施: placebo (Drug)
结局指标
主要结局
The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence
次要结局
- - AF/AFL related symptoms collected at the time of ECG/TTEM recording,
- - mean ventricular rate during AF/AFL at first recorded AF/AFL recurrence (12-lead ECG or TTEM)
- - time from presumed study drug near steady state defined as D5 midnight to first documented AF/AFL recurrence as indicated by ECG/TTEM recording.