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

Conditions

• Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

First listed

Jul 29, 2026

Start date

Jul 15, 2025

Status verified

Jul 2026

Primary completion

May 15, 2026

Completion

Aug 15, 2026

Study Design

Enrollment

4,006 participants (actual)

Arms

• Arm: Alirocumab
• Arm: Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents)

Primary Outcome Measure

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