Impact of Alirocumab on Cardiovascular Events in Individuals With Atherosclerotic Cardiovascular Disease But Without Prior Ischemic Events
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 4,545
- 试验地点
- 1
研究概览
简要总结
The objective of this study is to evaluate ischemic event rates among individuals with established atherosclerotic cardiovascular disease without prior acute ischemic events, comparing those treated with alirocumab versus those receiving no proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) therapy. The study will leverage observational data reflective of routine clinical practice and will apply contemporary approaches in target trial emulation and causal inference to estimate treatment effects.
详细描述
The study aims to estimate the reduction in major cardiovascular events (MACE) with intensive lipid lowering therapy (LLT) via Alirocumab in a population with ASCVD but without a history of ischemic events. The current study will closely mirror the adopted methodological approach for the prior investigation of the impact of PCSK9i mAb class on MACE in this population.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants (aged ≥18 years at index) with ASCVD without evidence of prior ischemic events (myocardial infarction, unstable angina, or ischemic stroke) will be included.
- •Participants initiating Alirocumab will be initially selected, with index (time zero) set as initiation of therapy. This index will be a point where the participants meet all the inclusion criteria in a hypothetical trial enrolling this population who would qualify for therapy.
排除标准
- •Participants with evidence of ischemic events either concurrent with or prior to the earliest record of ASCVD will be excluded.
- •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 (either mAb or siRNA)
干预措施: Comparator: No PCSK9i Therapy (either mAb or siRNA) (Drug)
Alirocumab
干预措施: Alirocumab (Drug)