Alirocumab and Ischemic Risk in Atherosclerotic Cardiovascular Disease (ASCVD)

Conditions

• Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Alirocumab — 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) — DRUG
  The study will not administer any treatment, only observe the treatment as prescribed in routine clinical practice.

Study Details

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.

Key Dates

Start date

Feb 17, 2025

Status verified

May 2026

Primary completion

May 30, 2026

Completion

May 30, 2026

Study Design

Enrollment

2,214 participants (estimated)

Arms

• Arm: Alirocumab
• Arm: Comparator: No PCSK9i Therapy (either mAb or siRNA)

Primary Outcome Measure

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

Locations (1)

Find similar trials in Bridgewater, NJ