Alirocumab and Ischemic Risk in Atherosclerotic Cardiovascular Disease (ASCVD)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events
• Intervention / Treatment: Drug: Alirocumab; Drug: Comparator: No PCSK9i Therapy (either mAb or siRNA)

Detailed Description

The study aims to estimate the reduction in major cardiovascular events (MACE) with intensive lipid lowering therapy (LLT) via Alirocumab in a population with ASCVD but without a history of ischemic events. The current study will closely mirror the adopted methodological approach for the prior investigation of the impact of PCSK9i mAb class on MACE in this population.

• Study Type: Observational
• Enrollment (Estimated): 2214

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Sanofi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.
• Participants initiating Alirocumab will be initially selected, with index (time zero) set as initiation of therapy. This index will be a point where the participants meet all the inclusion criteria in a hypothetical trial enrolling this population who would qualify for therapy.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Alirocumab	Drug: Alirocumab; 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)	Drug: Comparator: No PCSK9i Therapy (either mAb or siRNA); The study will not administer any treatment, only observe the treatment as prescribed in routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite of nonfatal myocardial infarction, nonfatal ischemic stroke, or all-cause mortality	From index up to 5 years follow up

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; RNA, Antisense; Antisense Elements (Genetics); RNA; RNA, Small Untranslated; RNA, Untranslated; alirocumab; RNA, Small Interfering
• Other Study ID Numbers: CEF0220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No