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NCT Number: NCT06287177

Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy

Evaluation of adherence, persistence and efficacy of treatment with Inclisiran in a real-life Italian population

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Federico II University of Naples, Department of Advanced Biomedical Sciences

Naples, 80131, Italy

Location status: Recruiting

Location contact

Pasquale Perrone Filardi, MD

CONTACT

[email protected]

0817462224

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients under Inclisiran treatment

Exclusion criteria

  • Age < 18 years o > 80 years
  • Patients who refuse to participate and to sign informed consent

Treatment and study plan

Inclisiran

Drug

Injection

Primary outcomes

  1. Description of adherence to treatment with Inclisiran in a real-life Italian population

    Time frame: at 3 months and every 6 months thereafter

    Adherence will be assessed in terms of Medical Possession Ratio (MPR) which is defined as the ratio between the treatment units dispensed during the treatment period and the duration of the treatment period itself.

  2. Description of persistence to treatment with Inclisiran in a real-life Italian population

    Time frame: at 3 months and every 6 months thereafter

    Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment.

  3. Description of efficacy of treatment with Inclisiran in a real-life Italian population

    Time frame: at 3 months and every 6 months thereafter

    Efficacy of treatment will be evaluated as a change in the LDL (deltaLDL) value from the start of treatment (percentage and absolute value). The deltaLDL will be calculated as an overall (mean and median value), by type of prevention (primary and secondary), by type of basic therapy, by demographic variables (age, sex, geographic origin, basal LDL levels) and by type of prescriber (hospital or territorial).

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy - CHOLINET (CHOLesterol Italian Inclisiran NETwork)

Acronym: CHOLINET

Important dates

Study start
2022
Primary completion
2024
Study completion
2030
First posted
Feb 29, 2024
Registry last updated
Jan 22, 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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