SLR/NMA of Multaq® vs Sotalol to Assess for Safety in Patients With Atrial Fibrillation (AFib)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 87,810
- 试验地点
- 1
- 主要终点
- Number of cardiovascular mortality events
研究概览
简要总结
A systematic literature review (SLR) will be conducted to understand the landscape of evidence on the relative safety and effectiveness/efficacy of dronedarone compared to sotalol in patients with AFib within interventional clinical trials and observational studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Following eligibility criteria are defined to select relevant studies from the literature
- •Adults with Atrial Fibrillation(AFib) (non-permanent, including paroxysmal or persistent, long-standing persistent AFib [over 12 months]))
- •Participants have received either Dronedarone or Sotalol
- •controlled clinical trials or comparative observational studies( prospective/retrospective cohort, case-control studies, population-based studies or registry based studies
排除标准
- •Exclusion criteria for potential participants are:
- •Children/adolescents
- •Permanent atrial fibrillation (AFib)
结局指标
主要结局
Number of cardiovascular mortality events
时间窗: As reported in studies included in the systematic review up to 10 years
includes arrhythmia-related mortality
Number of all-cause mortality events
时间窗: As reported in studies included in the systematic review up to 10 years
Number of participants with Cardiovascular (CV) hospitalization
时间窗: As reported in studies included in the systematic review up to 10 years
CV hospitalization is defined as composite of heart failure hospitalization, AFib hospitalization, MI, and stroke
Number of participants with ventricular proarrhythmia
时间窗: As reported in studies included in the systematic review up to 10 years
Number of participants with atrial fibrillation (AFib) recurrence
时间窗: As reported in studies included in the systematic review up to 10 years
次要结局
- Number of participants with AFib hospitalization(As reported in studies included in the systematic review up to 10 years)
- Number of participants with myocardial infarction(As reported in studies included in the systematic review up to 10 years)
- Number of participants with stroke(As reported in studies included in the systematic review up to 10 years)
- Number of participants with heart failure hospitalization(As reported in studies included in the systematic review up to 10 years)
- Number of participants with conduction disorders(As reported in studies included in the systematic review up to 10 years)