A Real-World Study of Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07543731
Status
Recruiting
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Conditions

  • Atherosclerotic Cardiovascular Disease
  • Cardiovascular Diseases
  • Hypercholesterolemia, Familial

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Study Details

This study aims to evaluate the long-term adherence and persistence to inclisiran and anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in real-world clinical practice.

Key Dates

First listed
Apr 22, 2026
Start date
Apr 2, 2026
Status verified
Jul 2026
Primary completion
Oct 30, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
5,995 participants (estimated)

Arms

  • Arm: Inclisiran Cohort
    Patients receiving inclisiran injection(s).
  • Arm: Evolocumab Cohort
    Patients receiving evolocumab injection(s).
  • Arm: Alirocumab Cohort
    Patients receiving alirocumab injection(s).
  • Arm: Pooled Anti-PCSK9-mAb Cohort
    Patients receiving anti-PCSK9-mAbs either evolocumab or alirocumab.

Primary Outcome Measure

Proportion of Days Covered (PDC) With Inclisiran [ Time Frame: 6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months ]

Central Contacts

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