A Phase IV, Double-blind, Placebo-controlled, Canadian Multicentre Study Comparing Two Treatment Strategies of Dronedarone Administration Following ELECTive caRdioversion for Prevention of Symptomatic Atrial Fibrillation (AF) Recurrence
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 292
- 试验地点
- 43
- 主要终点
- Proportion of participants with at least one symptomatic, ECG confirmed, AF recurrence
研究概览
简要总结
Primary Objective:
To determine whether daily administration of dronedarone started 5-7 days before cardioversion is superior to dronedarone started only after cardioversion with respect to the absence of symptomatic, ECG confirmed, atrial fibrillation (AF) recurrence over 6 months in adult patients with persistent AF, for whom cardioversion is clinically indicated and planned to reduce symptoms and antiarrhythmic treatment is clinically indicated to reduce the risk of cardiovascular hospitalization due to AF.
Secondary Objectives:
Main Secondary :
- To assess the number of symptomatic AF recurrences/patient/6 months with and without ECG confirmation;
- To assess characteristics of symptomatic AF recurrence in the two treatment arms (frequency, duration of episodes, type, number, and severity of AF symptoms per patient);
- To compare the rates of early recurrences of AF between the two treatment strategies;
Other secondary:
- To assess whether there is a difference in proportion of patients with symptomatic AF recurrences (with and without ECG confirmation) between the two treatment strategies;
- To assess whether there is a difference in number of electrical cardioversions per patient between the two treatment strategies;
- To assess the impact of the two strategies on number of shocks, cumulative amount of energy delivered, shock failure, and immediate success of cardioversion;
- To assess whether there is a difference in rate of cardiovascular (CV) hospitalizations and length of hospital stay between the two treatment strategies;
- To assess whether there is a difference in quality of life between the two treatment strategies.
详细描述
The study period of approximatively 6 months consisted in:
- Double-blind treatment period (placebo or dronedarone) for 5-7 days prior to cardioversion;
- Electrical cardioversion;
- Open-label treatment period with dronedarone for 6 months after cardioversion.
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
- 18 Years 至 —（Adult, 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 pre-cardioversion
Dronedarone 400 mg twice a day for 5-7 days prior to cardioversion, then dronedarone 400 mg twice a day for 6 months after cardioversion
干预措施: Dronedarone (Drug)
Placebo pre-cardioversion
Placebo (for dronedarone) twice a day for 5-7 days prior to cardioversion, then dronedarone 400 mg twice a day for 6 months after cardioversion
干预措施: Dronedarone (Drug)
Placebo pre-cardioversion
Placebo (for dronedarone) twice a day for 5-7 days prior to cardioversion, then dronedarone 400 mg twice a day for 6 months after cardioversion
干预措施: Placebo (for dronedarone) (Drug)
结局指标
主要结局
Proportion of participants with at least one symptomatic, ECG confirmed, AF recurrence
时间窗: 6 months from initial cardioversion
次要结局
- Cumulative Amount of Energy Delivered and Shock Failure(during the initial cardioversion)
- Number of Symptomatic AF Recurrences/Patient/6 Months (With or Without ECG Confirmation)(up to 6 months from initial cardioversion)
- Characteristics of Symptomatic AF Recurrence (Frequency, Duration of Episodes, Type, Number, and Severity of AF Symptoms)(up to 6 months from initial cardioversion)
- Proportion of Participants With Symptomatic AF Recurrences (With or Without ECG Confirmation)(up to 6 months from initial cardioversion)
- Number of Shocks Required During Initial Cardioversion(during the initial cardioversion)
- Number of Electrical Cardioversions Per Patient(up to 6 months from intial cardioversion)
- Proportion of Participants With Early Recurrence of AF (i.e. From 5 Minutes to to 7 Days Following Cardioversion)(up to 7 days following initial cardioversion)
- Proportion of Participants With Immediate Recurrence of AF (From 5 Seconds to 5 Minutes After Electrical Shock)(during the initial cardioversion)
- Number of CV Hospitalizations(up to 6 months from initial cardioversion)
- Quality of Life, as Measured by Atrial Fibrillation Severity Scale (AFSS) and Atrial Fibrillation Effect on Quality of Life (AFEQT) Questionnaires(Baseline and 6 months after initial cardioversion)