A Randomized, Double Blind, Placebo Controlled, Parallel Group Trial for Assessing the Clinical Benefit of Dronedarone 400mg 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
- 终止
- 发起方
- Sanofi
- 入组人数
- 3,236
- 试验地点
- 1
- 主要终点
- Overview of the Two Co-primary Outcomes
研究概览
简要总结
Primary Objective:
- Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation [AF] and additional risk factors
Secondary Objective:
- Demonstrate the efficacy of Dronedarone in preventing cardiovascular death
This was an event-driven study where a common study end date [CSED] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death).
详细描述
The study period per participant was variable depending on the enrollment in the study.
A final follow-up visit had to occur within 1 month after the CSED.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dronedarone
Dronedarone 400 mg twice a day until the CSED
干预措施: Dronedarone (Drug)
placebo
Placebo (for Dronedarone) twice a day until the CSED
干预措施: Placebo (for Dronedarone) (Drug)
结局指标
主要结局
Overview of the Two Co-primary Outcomes
时间窗: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
First co-primary outcome was defined as the first event among stroke, systemic arterial embolism, Myocardial Infarctions \[MI\], or cardiovascular death. Second co-primary outcome was defined as the first event among unscheduled cardiovascular hospitalization or death from any cause. Both co-primary outcomes were determined based on the central review and adjudication by a blinded Adjudication Committee of all reported deaths (from any cause), MI, systemic arterial embolisms, strokes, Transient Ischemic Attacks \[TIA\], Heart Failure hospitalization and unplanned hospitalisations for cardiovascular cause.
Time to First Co-primary Outcome (Cumulative Incidence Function)
时间窗: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
Time to first co-primary outcome was defined as the time from randomization to the first event among stroke, systemic arterial embolism, MI or cardiovascular death. Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate. 95% confidence interval was computed at each time-point using Greenwood's variance estimation.
Time to Second Co-primary Outcome (Cumulative Incidence Function)
时间窗: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
Time to second co-primary outcome was defined as the time from randomization to the first event among unscheduled cardiovascular hospitalization or death from any cause. Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate. 95% confidence interval was computed at each time-point using Greenwood's variance estimation.
次要结局
- Deaths(From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year))
- Time to Cardiovascular Death (Cumulative Incidence Function)(From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year))