NCT01856075已完成不适用
Relative Effectiveness of Dronedarone vs. Other Treatments of Atrial Fibrillation
La-ser Europe Limited1 个研究点 分布在 1 个国家目标入组 1,015 人开始时间: 2012年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,015
- 试验地点
- 1
- 主要终点
- Change from baseline Recurrence of Atrial Fibrillation
研究概览
简要总结
This is an international observational multicentre study to be conducted in Germany, Spain, Italy and USA. The main objective of the study is to evaluate the relative effectiveness of dronedarone in real world clinical practice versus other anti-arrhythmic agents of interest. The design of the study is a historic-prospective cohort with dynamic exposure and stratified competitive recruitment with balanced comparison groups of dronedarone versus alternative antiarrhythmic drugs of interest.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •Patient 18 years old or above
- •Patient with paroxysmal or persistent atrial fibrillation
- •Patient using an AAi (antiarrhythmic drug of interest) or dronedarone (index drug)
- •Patient's treatment changed from one AAi to another AAi or dronedarone OR from no antiarrhythmic therapy to the start of AAi or dronedarone therapy during previous 6 months before the date of recruitment
- •Patient with at least 6 months of medical and treatment information prior to the start of the index drug
- •Patient able to answer the telephone interview in a language of the participating country: English, German, Italian or Spanish (with or without proxy).
排除标准
- •Patient with heart failure (NYHA class IV)
- •Patient with permanent Atrial Fibrillation
- •Patient with psychiatric conditions preventing the participation to the study according to the physician
结局指标
主要结局
Change from baseline Recurrence of Atrial Fibrillation
时间窗: 3 month; 6 month; 12-18 month
Assessment of the recurrence of atrial fibrillation (change from baseline) at 3 month, 6 month, and 12-18 month of follow-up
次要结局
- Change from baseline AV node ablation and catheter ablation for Atrial Fibrillation(3 month; 6 month; 12-18 month)
- Change from baseline Progression to permanent Atrial Fibrillation(3 month; 6 month; 12-18 month)
- Change from baseline Congestive heart failure(3 month; 6 month; 12-18 month)
- Change from baseline Interstitial pulmonary disease(3 month; 6 month; 12-18 month)
- Change from baseline Renal insufficiency/failure(3 month; 6 month; 12-18 month)
- Change from baseline Torsade de pointes(3 month; 6 month; 12-18 month)
- Change from baseline Liver injury/toxicity(3 month; 6 month; 12-18 month)
- Change from baseline Myocardial infarction(3 month; 6 month; 12-18 month)
- Change from baseline Cardiovascular hospitalisation(3 month; 6 month; 12-18 month)
- Death(3 month; 6 month; 12-18 month)
- Change from baseline Clinical progression to heart failure and left ventricular systolic dysfunction(3 month; 6 month; 12-18 month)
- Change from baseline Cerebrovascular accident/Stroke(3 month; 6 month; 12-18 month)
研究者
研究点 (1)
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