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Alirocumab and Ischemic Risk in Atherosclerotic Cardiovascular Disease (ASCVD)

CompletedN/A

Sponsor: Sanofi

Conditions: Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events

Interventions: Alirocumab, Comparator: No PCSK9i Therapy (either mAb or siRNA)

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Locations (1)

Bridgewater, New Jersey, United States