Alirocumab and Cardiovascular Outcomes in Patients Without a Previous Myocardial Infarction or Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 4,006
- 试验地点
- 1
- 主要终点
- Composite of Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or All-Cause Mortality
研究概览
简要总结
To estimate ischemic event rates in individuals with established atherosclerotic cardiovascular disease (ASCVD) and no prior acute ischemic events, comparing alirocumab with no Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitor therapy, using a target trial emulation of routine clinical practice data.
详细描述
This study estimates the effect of alirocumab versus no PCSK9 inhibitor on major cardiovascular events in individuals with established ASCVD and no prior ischemic events, using a target trial emulation of routine clinical practice data from the Netherlands.
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
- •Adults aged ≥18 years with documented ASCVD between January 1, 2016, and September 30,
- •No history of myocardial infarction, ischemic stroke, or hospitalization for unstable angina on or before the index date.
- •Minimum of 12 months of continuous healthcare data availability prior to the index date
- •No exposure to any PCSK9 inhibitor in the 2 years preceding the index date.
排除标准
- •- Participants with a history of prior ischemic events.
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents)
干预措施: Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents) (Drug)
Alirocumab
干预措施: Alirocumab (Drug)
结局指标
主要结局
Composite of Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or All-Cause Mortality
时间窗: From index up to 5 years follow up
次要结局
未报告次要终点