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Alirocumab and Ischemic Risk in Atherosclerotic Cardiovascular Disease (ASCVD)
Sponsor: Sanofi
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.
Official title: Impact of Alirocumab on Cardiovascular Events in Individuals With Atherosclerotic Cardiovascular Disease But Without Prior Ischemic Events
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
OBSERVATIONAL
Enrollment
2214
Start Date
2025-02-17
Completion Date
2026-05-30
Last Updated
2026-05-29
Healthy Volunteers
No
Interventions
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)
The study will not administer any treatment, only observe the treatment as prescribed in routine clinical practice.
Locations (1)
Sanofi
Bridgewater, New Jersey, United States