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

Sanofi4,006 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

4,006

Conditions

Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events

Interventions

AlirocumabDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi

Amsterdam, Netherlands

Outcomes

Primary Outcomes

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

Time frame: From index up to 5 years follow up

Data from ClinicalTrials.gov

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