Clinical Trial

Alirocumab and Ischemic Risk in Atherosclerotic Cardiovascular Disease (ASCVD)

Study acronym: OPTIMUS-IMPACT
Completed
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 3 changes
critical Trial completed 2026-06-16
notable Enrollment increased: 2214 -> 4545 participants 2026-06-16
notable Primary completion moved earlier: 2026-05-30 -> 2025-09-30 2026-06-16
Trial Details
NCT Number NCT07615179
Lead Sponsor Sanofi
Conditions Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events
Enrollment 4,545 participants
Start Date 2025-02-17
Primary Completion 2025-09-30 (estimated)
Study Completion 2026-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-15