A randomized, double blind, placebo controlled, parallel group trial for assessing the clinical benefit of dronedarone 400 mg BID on top of standard therapy in patients with permanent atrial fibrillation and additional risk factors
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 10,800
- 试验地点
- 28
- 主要终点
- 1.Composite endpoint of first stroke, systemic arterial embolism,
研究概览
简要总结
Trial will be conducted in 43 countries all over the world. Globally study start date is July 2010. Globally estimated study competion date and estimated primary completion date is August 2013. The Indian target - 550 patients Indian status - 0 patients randomized till date Planned date of first enrolment - 04 July 2011
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 65.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients in permanent atrial fibrillation with additional risk factors
- •Patients in permanent atrial fibrillation defined by the presence of all of the following criteria:
- •Availability of one 12-lead ECG not more than 14 days prior to randomization, showing that the patient is in atrial fibrillation or atrial flutter
- •Availability of documentation (including either rhythm strips or medical report of the rhythm) showing that the patient was in atrial fibrillation or atrial flutter at least 6 months prior to randomization
- •No evidence of sinus rhythm in the period between these two documentations of atrial fibrillation
- •Patient and physician decision to allow atrial fibrillation to continue without further efforts to restore sinus rhythm 5.Patients aged 65 years or older with at least one of the following risk factors or combination of risk factors: 1.Coronary artery disease
- •Prior stroke or TIA
- •Symptomatic heart failure
- •Left ventricular ejection fraction less than or equal to 0.40
- •Peripheral arterial occlusive disease
- •Aged 75 years or older with both hypertension and diabetes mellitus".
排除标准
- •"Exclusion Criteria (selection) E
- •Patients in paroxysmal atrial fibrillation E
- •Patients in persistent atrial fibrillation without a decision to allow atrial fibrillation to continue without further efforts to restore sinus rhythm E
- •Patients with heart failure of NYHA class IV or recent unstable NYHA class III".
结局指标
主要结局
1.Composite endpoint of first stroke, systemic arterial embolism,
时间窗: 1.The Common Study End Date will be anticipated based on the | projected blind number of events to reach 844 coprimary events not | refuted by adjudication (stroke, systemic arterial embolism, | myocardial infarction or cardiovascular death) but cannot be less | than 3 months after the last patient randomized
myocardial infarction or cardiovascular death
时间窗: 1.The Common Study End Date will be anticipated based on the | projected blind number of events to reach 844 coprimary events not | refuted by adjudication (stroke, systemic arterial embolism, | myocardial infarction or cardiovascular death) but cannot be less | than 3 months after the last patient randomized
2.Composite endpoint of first unplanned cardiovascular
时间窗: 1.The Common Study End Date will be anticipated based on the | projected blind number of events to reach 844 coprimary events not | refuted by adjudication (stroke, systemic arterial embolism, | myocardial infarction or cardiovascular death) but cannot be less | than 3 months after the last patient randomized
hospitalization or death from any cause
时间窗: 1.The Common Study End Date will be anticipated based on the | projected blind number of events to reach 844 coprimary events not | refuted by adjudication (stroke, systemic arterial embolism, | myocardial infarction or cardiovascular death) but cannot be less | than 3 months after the last patient randomized
次要结局
未报告次要终点