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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07734753

Acronym

OPTIMUS-EPIC

Enrollment

4006

Registered

2026-07-29

Start date

2025-07-15

Completion date

2026-08-15

Last updated

2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events

Brief 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.

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.

Interventions

DRUGAlirocumab

The study will not administer any treatment, only observe the treatment as prescribed in routine clinical practice.

DRUGComparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents)

The study will not administer any treatment, only observe the treatment as prescribed in routine clinical practice.

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026