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

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

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

Study Overview

• Status: Recruiting
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Inclisiran

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 80131
    • Recruiting
    • Federico II University of Naples, Department of Advanced Biomedical Sciences
    • Contact: Pasquale Perrone Filardi, MD; Phone Number: 0817462224; Email: fpperron@unina.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population includes patients from Italy, who have received Inclisiran as part of routine clinical management of their hyperlipidaemia, based on national reimbursement criteria, at time of enrollment

Description

Inclusion Criteria:

• Patients under Inclisiran treatment

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with hyperlipidaemia under Inclisiran treatment	Drug: Inclisiran; Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of adherence to treatment with Inclisiran in a real-life Italian population	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.	3-6-12 months
Description of persistence to treatment with Inclisiran in a real-life Italian population	Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment.	3-6-12 months
Description of efficacy of treatment with Inclisiran in a real-life Italian population	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).	3-6-12 months

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): February 29, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: Protocol 28/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No