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

NCT07734753 | Active Not Recruiting FDA Drug

• 1 other identifier: SEC27141
• Study Type: observational
• Target: 4,006
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events

Outcome Measures

Primary Outcomes (1)

• Composite of Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or All-Cause Mortality

  From index up to 5 years follow up

Study Arms (2)

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)

Interventions

Alirocumab DRUG

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

Alirocumab

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The eligible population includes adults aged ≥18 years with documented ASCVD and no history of myocardial infarction, ischemic stroke, or hospitalization for unstable angina.

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi

Amsterdam, 1105 BP, Netherlands

Location

MeSH Terms

Interventions

alirocumab; Antibodies, Monoclonal

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start: July 15, 2025
• Primary Completion: May 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)