HypercholesterolemiaCHOLINETNCT06287177
Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy
An observational study of Hypercholesterolemia, run by Federico II University at 1 site in Italy.
Trial summary
Evaluation of adherence, persistence and efficacy of treatment with Inclisiran in a real-life Italian population Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Inclisiran
- Type of treatment
- Injection or infusion
- How many people
- 3,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2022to 1 Nov 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients under Inclisiran treatment
Who cannot join
- Age < 18 years o > 80 years
- Patients who refuse to participate and to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Federico II University of Naples, Department of Advanced Biomedical Sciences
Naples, 80131
Pasquale Perrone Filardi, MD, 0817462224, fpperron@unina.it
About this study
Official title: 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
- Conditions
- Hypercholesterolemia
- Being tested
- Inclisiran
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InclisiranDrug
Injection
| Study group | Role | What they receive |
|---|---|---|
| Subjects with hyperlipidaemia under Inclisiran treatment | Not described Receives: Drug: Inclisiran |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: at 3 months and every 6 months thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Nov 2022
- Primary completion29 Feb 2024
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pasquale Perrone Filardi, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287177
- Sponsor's protocol ID
- Protocol 28/2023
- Acronym
- CHOLINET
- Status last verified
- Jan 2026
- First submitted
- 20 Feb 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy - CHOLINET (CHOLesterol Italian Inclisiran NETwork)
- ClinicalTrials.gov ID
- NCT06287177
- Acronym / sponsor ID
- CHOLINET / Protocol 28/2023
- Conditions
- Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of adherence, persistence and efficacy of treatment with Inclisiran in a real-life Italian population
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with hyperlipidaemia under Inclisiran treatment | – | Drug: Inclisiran |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients under Inclisiran treatment
Key exclusion criteria (2 listed)
- Age < 18 years o > 80 years
- Patients who refuse to participate and to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InclisiranInjection | Drug | Subjects with hyperlipidaemia under Inclisiran treatment |
Primary outcome
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.
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Federico II University of Naples, Department of Advanced Biomedical Sciences
Naples, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of adherence to treatment with Inclisiran in a real-life Italian population (time frame: at 3 months and every 6 months thereafter). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.