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NCT Number: NCT07543731

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

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.

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Key information

Conditions

Cardiovascular Diseases Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Atherosclerotic Cardiovascular Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hypercholesterolemia, Familial Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

Basel, CH-4056, Switzerland

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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

    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.

  2. Annual PDC With Inclisiran

    Time frame: 0-12 months, 12-24 months, 24-48 months

    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.

  3. Persistence With Inclisiran Treatment

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

    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.

Secondary outcomes

  1. PDC With Anti-PCSK9-mAbs

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

    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.

  2. Annual PDC With Anti-PCSK9-mAbs

    Time frame: 0-12 months, 12-24 months, 24-48 months

    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.

  3. Persistence With Anti-PCSK9-mAb Treatment

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

    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.

  4. Baseline Demographics

    Time frame: Baseline

  5. Baseline Clinical Characteristics: Number of Patients by Diagnosis

    Time frame: Baseline

    Diagnoses include primary hypercholesterolemia, mixed dyslipidemia, homozygous familial hypercholesterolemia, and atherosclerotic cardiovascular disease (ASCVD) where available.

  6. Baseline Clinical Characteristics: Number of Patients by Comorbidity

    Time frame: Baseline

  7. Baseline Clinical Characteristics: Charlson Comorbidity Index (CCI) Score

    Time frame: Baseline

    CCI is a weighted index that takes into account both the number and the seriousness of comorbid diseases. It predicts the ten-year mortality for a patient who may have a range of comorbid conditions. CCI can be categorized as low (0-1) and high (≥2).

  8. PDC With Lipid Lowering Therapies (LLTs) at Baseline

    Time frame: Baseline

    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.

  9. Number of Patients by LLTs Received

    Time frame: Every 3 months from baseline through index date until the end of follow-up, assessed up to 48 months

    Treatment patterns of LLT use. Index date is the date of first use of the treatment.

  10. Number and Percentage of Patients Receiving Each of the Inclisiran Doses

    Time frame: From index date until the end of follow-up, assessed up to 48 months

    Index date is the date of first use of the treatment.

  11. Time Between Inclisiran Doses

    Time frame: From index date until the end of follow-up, assessed up to 48 months

    Index date is the date of first use of the treatment.

  12. Number of Anti-PCSK9-mAb Prescriptions

    Time frame: From index date until the end of follow-up, assessed up to 48 months

    Index date is the date of first use of the treatment.

  13. Time Between Anti-PCSK9-mAb Prescriptions

    Time frame: From index date until the end of follow-up, assessed up to 48 months

    Index date is the date of first use of the treatment.

  14. Association Between Treatment Adherence and Baseline Characteristics per Cohort

    Time frame: Baseline, up to 48 months

    Multivariable regression models will be used to examine how baseline characteristics could be associated with treatment adherence per cohort. Baseline characteristics may include age, sex, diagnosis, cardiovascular events, comorbidities, adherence to LLTs, and number of medications received at index and post-index.

  15. Association Between Treatment Persistence and Baseline Characteristics per Cohort

    Time frame: Baseline, up to 48 months

    Cox proportional hazards models will be used to examine how baseline characteristics could be associated with treatment persistence per cohort. Baseline characteristics may include age, sex, diagnosis, cardiovascular events, comorbidities, adherence to LLTs, and number of medications received at index and post-index.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Real-World Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab in Italy

Acronym: VICTORION-LEAP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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