Alirocumab and Ischemic Risk in Atherosclerotic Cardiovascular Disease (ASCVD)

NCT07615179 | Completed FDA Drug

• 1 other identifier: CEF0220
• Study Type: observational
• Target: 4,545
• Locations: 1 country
• Sites: 1

Brief 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.

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 (either mAb or siRNA)

Drug: Comparator: No PCSK9i Therapy (either mAb or siRNA)

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 (either mAb or siRNA) DRUG

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

Comparator: No PCSK9i Therapy (either mAb or siRNA)

Eligibility Criteria

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

Study Population

Participants who initiated treatment with Alirocumab from January 01, 2016 till December 31, 2022.

You may qualify if:

• Adult participants (aged ≥18 years at index) with ASCVD without evidence of prior ischemic events (myocardial infarction, unstable angina, or ischemic stroke) will be included.

You may not qualify if:

• Participants with evidence of ischemic events either concurrent with or prior to the earliest record of ASCVD will be excluded.
• 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

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Interventions

alirocumab; RNA, Small Interfering

Intervention Hierarchy (Ancestors)

RNA, Antisense; Antisense Elements (Genetics); Nucleic Acids, Nucleotides, and Nucleosides; RNA; Nucleic Acids; RNA, Small Untranslated; RNA, Untranslated

Study Design

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

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: February 17, 2025
• Primary Completion: September 30, 2025
• Study Completion: May 30, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)