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

NCT06287177 | Recruiting DMC FDA Drug

• 1 other identifier: Protocol 28/2023
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (3)

• 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.

  at 3 months and every 6 months thereafter

• 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.

  at 3 months and every 6 months thereafter

• 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).

  at 3 months and every 6 months thereafter

Study Arms (1)

Subjects with hyperlipidaemia under Inclisiran treatment

Drug: Inclisiran

Interventions

Inclisiran DRUG

Injection

Subjects with hyperlipidaemia under Inclisiran treatment

Eligibility Criteria

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

You may qualify if:

• Patients under Inclisiran treatment

You may not qualify if:

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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University of Naples, Department of Advanced Biomedical Sciences

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

ALN-PCS

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 29, 2024
• Study Start: November 1, 2022
• Primary Completion: February 29, 2024
• Study Completion (Estimated): November 1, 2030
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)