Alirocumab and Ischemic Risk in Atherosclerotic Cardiovascular Disease (ASCVD)

Completed

Conditions studied: Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events

In brief

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.

Key facts

Study ID

NCT07615179

Run by

Sanofi

People needed

4545

Starts

2025-02-17

Expected to finish

2026-05-30

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sanofi — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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