Impact of Alirocumab on Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease But Without Prior Ischemic Events

NCT07734753 — Completed, 4006 participants, Sanofi

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Alirocumab and Cardiovascular Outcomes in Patients Without a Previous Myocardial Infarction or Stroke

Registry	NCT07734753, acronym OPTIMUS-EPIC
Status	Completed
Study type	Observational
Enrollment	4006 (Actual)
Sponsor	Sanofi (Industry)
Conditions	Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events
Interventions	Alirocumab, Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents) (Drug)
Dates	start 2025-07-15, primary completion 2026-05-15, completion 2026-08-15, first posted 2026-07-29, last updated 2026-09-11
Locations	1 site in Netherlands

-Summary

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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Alirocumab		Drug: Alirocumab
Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents)		Drug: Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents)

Alirocumab (Drug): The study will not administer any treatment, only observe the treatment as prescribed in routine clinical practice.
Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents) (Drug): The study will not administer any treatment, only observe the treatment as prescribed in routine clinical practice.

+Outcome measures

Primary outcomes

Composite of Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or All-Cause Mortality [From index up to 5 years follow up]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Adults aged ≥18 years with documented ASCVD between January 1, 2016, and September 30, 2024.
* 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.

Exclusion Criteria:

\- 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.

+Locations (1)

Facility	City	Country	Status
Sanofi	Amsterdam	Netherlands