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NCT06287177 Clinical Trial

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

Hypercholesterolemia Clinical Trial

— CHOLINET  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06287177
Other study ID # Protocol 28/2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2022
Est. completion date November 1, 2024

Study information
Verified date March 2024
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date November 1, 2024
Est. primary completion date February 29, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Inclisiran
Injection

Locations
Country Name City State
Italy Federico II University of Naples, Department of Advanced Biomedical Sciences Napoli

Sponsors (1)
Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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