HypercholesterolemiaAT-TARGET-ITNCT05430828
Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy
An observational study of Hypercholesterolemia, run by Federico II University at 27 sites in Italy.
Trial summary
Evaluation of adherence, persistence and efficacy of treatment with PCSK9 inhibitors in a real-life Italian population. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Repatha (evolocumab); Praluent (alirocumab)
- Type of treatment
- Injection or infusion
- How many people
- 5,000 participants
- Where
- 27 sitesItaly
- Study dates
- 7 Mar 2020to 31 Mar 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes patients from Italy, who have received PCSK9 inhibitor as part of routine clinical management of their hyperlipidaemia for at least 6 months at time of enrollment, based on national reimbursement criteria.
Who may be able to join
- Patients under PCSK9 inhibitor treatment.
Who cannot join
- Age < 18 years o > 80 years;
- Patients who refuse to participate and to sign informed consent.
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
Italy27 sites, 26 recruiting
- Recruiting
Ospedali dell'Ovest Vicentino
Arzignano, 36071
Claudio Bilato, MD
- Recruiting
University of Bari Aldo Moro
Bari, 70121
Marco Matteo Ciccone, MD
- Recruiting
University of Campania Luigi Vanvitelli
Caserta, 81100
Paolo Calabrò, MD
- Recruiting
University Magna Graecia of Catanzaro
Catanzaro, 88100
Ciro Indolfi, MD
- Recruiting
Presidio Ospedaliero Maria SS Addolorata
Eboli, 84025
Angelo Catalano, MD
- Recruiting
Policlinico Riuniti Foggia
Foggia, 71122
Natale Brunetti, MD
- Recruiting
Università degli Studi di Genova
Genova, 16126
Italo Porto, MD
- Recruiting
Ospedale di Lecce
Lecce, 73100
Giuseppe Colonna, MD
- Recruiting
Università degli Studi di Messina
Messina, 98122
Giuseppe Andò, MD
- Recruiting
Policlinico di Milano Ospedale Maggiore - Fondazione IRCCS Ca' Granda
Milan, 20122
Stefano Carugo, MD
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Piera Merlini, MD
Alessandro Maloberti, MD
- Recruiting
AORN dei Colli - Ospedale monaldi
Naples, 80131
Mario Crisci, MD
- Recruiting
Federico II University of Naples, Department of Advanced Biomedical Sciences
Naples, 80131
Pasquale Perrone Filardi, MD
- Recruiting
Federico II University of Naples, Department of Translational Medical Sciences
Naples, 80131
Francesco Giallauria, MD
- Recruiting
University of Naples Federico II, Department of Clinical Medicine and Surgery
Naples, 80131
Gabriella Iannuzzo, MD
- Recruiting
Azienda Ospedaliero-Universitaria "Maggiore della Carità"
Novara, 28100
Giuseppe Patti, MD
- Recruiting
Azienda Ospedaliero-Univeristaria di Parma
Parma, 43126
Giampaolo Niccoli, MD
- Recruiting
Presidio Ospedaliero Pescara
Pescara, 65124
Leonardo Paloscia, MD
- Recruiting
Ospedale di Rivoli
Rivoli, 10098
Fernando Varbella, MD
Antonella Corleto, MD
- Recruiting
Policlinico Tor Vergata
Roma, 00133
Saverio Muscoli, MD
- Recruiting
Azienda Ospedaliera San Camillo-Forlanini
Roma, 00152
Leonardo De Luca, MD
- Recruiting
Policlinico Casilino
Roma, 00169
Leonardo Calò, MD
- Withdrawn
Sapienza University of Rome
Roma, 00185
- Recruiting
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
Salerno, 84131
Gennaro Galasso, MD
- Recruiting
Ospedale SS Annunziata A.O.U.
Sassari, 07100
Gavino Casu, MD
- Recruiting
University of Siena
Siena, 53100
Matteo Cameli, MD
- Recruiting
Azienda Ospedaliera Ordine Mauriziano Torino
Torino, 10128
Giuseppe Musumeci, MD
About this study
Official title: Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy
Evaluation of adherence, persistence and efficacy of treatment with PCSK9 inhibitors in a real-life Italian population.
- Conditions
- Hypercholesterolemia
- Being tested
- Repatha (evolocumab); Praluent (alirocumab)
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repatha (evolocumab); Praluent (alirocumab)Drug
Dosage form: Injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Subjects with hyperlipidaemia under PCSK9 inhibitors treatment (Repatha/Praulent). Receives: Drug: Repatha (evolocumab); Praluent (alirocumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of adherence of treatment with PCSK9 inhibitors 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. MPR will be calculated as overall MPR (mean and median value), MPR by type of prevention (primary and secondary), MPR by type of antiPCSK9 inhibitor (alirocumab vs. evolocumab), MPR by type of background therapy (statin yes, statin no) , MPR by demographic variables (age, sex, geographic origin, basal LDL levels), MPR by type of prescriber (hospital or territorial).
Measured: every 6 months
Description of persistence of treatment with PCSK9 inhibitors in a real-life Italian population.
Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment.
Measured: every 6 months
Description of efficacy of treatment with PCSK9 inhibitors 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 antiPCSK9 inhibitor (alirocumab vs. evolocumab), by type of basic therapy (statin yes, statin no), by demographic variables (age, sex, geographic origin, basal LDL levels), by type of prescriber (hospital or territorial).
Measured: every 6 months
Secondary outcomes (1)
Description of adherence, efficacy and safety of treatment with PCSK9 inhibitors in a real-life Italian population general and divided into subgroups.
Safety will be evaluated in terms of adverse reactions or intolerance to the drug.
Measured: every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start7 Mar 2020
- Primary completion30 Jan 2022
- Study completion31 Mar 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
- 5,000 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
- NCT05430828
- Sponsor's protocol ID
- 264/20
- Acronym
- AT-TARGET-IT
- Status last verified
- Jan 2026
- First submitted
- 20 Jun 2022
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 PCSK9 Inhibitors in Italy
- ClinicalTrials.gov ID
- NCT05430828
- Acronym / sponsor ID
- AT-TARGET-IT / 264/20
- Conditions
- Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 7 Mar 2020 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 24 Jun 2022 (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 PCSK9 inhibitors in a real-life Italian population.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Repatha (evolocumab); Praluent (alirocumab)Subjects with hyperlipidaemia under PCSK9 inhibitors treatment (Repatha/Praulent). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients from Italy, who have received PCSK9 inhibitor as part of routine clinical management of their hyperlipidaemia for at least 6 months at time of enrollment, based on national reimbursement criteria.
Key inclusion criteria (1 listed)
- Patients under PCSK9 inhibitor 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 |
|---|---|---|
| Repatha (evolocumab); Praluent (alirocumab)Dosage form: Injection | Drug | Group 1 |
Primary outcome
Description of adherence of treatment with PCSK9 inhibitors in a real-life Italian population.
Time frame: every 6 months
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. MPR will be calculated as overall MPR (mean and median value), MPR by type of prevention (primary and secondary), MPR by type of antiPCSK9 inhibitor (alirocumab vs. evolocumab), MPR by type of background therapy (statin yes, statin no) , MPR by demographic variables (age, sex, geographic origin, basal LDL levels), MPR by type of prescriber (hospital or territorial).
Description of persistence of treatment with PCSK9 inhibitors in a real-life Italian population.
Time frame: every 6 months
Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment.
Description of efficacy of treatment with PCSK9 inhibitors in a real-life Italian population.
Time frame: every 6 months
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 antiPCSK9 inhibitor (alirocumab vs. evolocumab), by type of basic therapy (statin yes, statin no), by demographic variables (age, sex, geographic origin, basal LDL levels), by type of prescriber (hospital or territorial).
1 secondary outcome
Description of adherence, efficacy and safety of treatment with PCSK9 inhibitors in a real-life Italian population general and divided into subgroups.
Time frame: every 6 months
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.
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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.
27 sites 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 27 sites 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 27 sites 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?
Contact Pasquale Perrone Filardi, MD (+390817462224, fpperron@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of adherence of treatment with PCSK9 inhibitors in a real-life Italian population. (time frame: every 6 months). 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.