Alirocumab and Ischemic Risk in Atherosclerotic Cardiovascular Disease (ASCVD)

N/AActive Not RecruitingNCT07615179

Sanofi2,214 enrolled

Overview

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.

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

2,214

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 (either mAb or siRNA)DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi

Bridgewater, New Jersey, United States

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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