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

NCT07543731 | Not Yet Recruiting

• 1 other identifier: CKJX839A12404
• Study Type: observational
• Target: 5,995
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cardiovascular Diseases; Atherosclerotic Cardiovascular Disease; Hypercholesterolemia, Familial

Keywords

Real-world; Retrospective; Adherence; Persistence; Long-term; PCSK9i

Outcome Measures

Primary Outcomes (3)

• Proportion of Days Covered (PDC) With Inclisiran

  PDC is defined as the number of days with medication supply (covered days) within a period of interest divided by the number of days in the period of interest. Index date is the date of first use of the treatment.

  6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months

• Annual PDC With Inclisiran

  PDC is defined as the number of days with medication supply (covered days) within a period of interest divided by the number of days in the period of interest.

  0-12 months, 12-24 months, 24-48 months

• Persistence With Inclisiran Treatment

  Persistence is defined as time to discontinuation by exceeding a pre-specified allowable gap beyond the scheduled time for the next dose/prescription. Index date is the date of first use of the treatment.

  6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months

Secondary Outcomes (15)

• PDC With Anti-PCSK9-mAbs

  6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months

• Annual PDC With Anti-PCSK9-mAbs

  0-12 months, 12-24 months, 24-48 months

• Persistence With Anti-PCSK9-mAb Treatment

  6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months

• Baseline Demographics

  Baseline

• Baseline Clinical Characteristics: Number of Patients by Diagnosis

  Baseline

Study Arms (4)

Inclisiran Cohort

Patients receiving inclisiran injection(s).

Evolocumab Cohort

Patients receiving evolocumab injection(s).

Alirocumab Cohort

Patients receiving alirocumab injection(s).

Pooled Anti-PCSK9-mAb Cohort

Patients receiving anti-PCSK9-mAbs either evolocumab or alirocumab.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients in Italy who initiated inclisiran, evolocumab, or alirocumab treatment during the identification period with at least 18 months of follow-up.

You may qualify if:

• A first ever prescription of injection of inclisiran, evolocumab, or alirocumab during the identification period.
• Age ≥18 years at index date.
• With at least 12 months data availability prior to index date.

You may not qualify if:

• Patients who received either evolocumab or alirocumab as their index study drug and who were dispensed the other anti-PCSK9-mAb (alirocumab and evolocumab respectively) before the identification period.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Cardiovascular Diseases; Atherosclerosis; Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 22, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share