Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy (AT-TARGET-IT)

January 21, 2026 updated by: Pasquale Perrone Filardi, Federico II University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Pasquale Perrone Filardi, MD
  • Phone Number: +390817462224
  • Email: fpperron@unina.it

Study Locations

  • Italy
      • Arzignano, Italy, 36071
        • Recruiting
        • Ospedali dell'Ovest Vicentino
        • Contact:
          • Claudio Bilato, MD
      • Bari, Italy, 70121
        • Recruiting
        • University of Bari Aldo Moro
        • Contact:
          • Marco Matteo Ciccone, MD
      • Caserta, Italy, 81100
        • Recruiting
        • University of Campania Luigi Vanvitelli
        • Contact:
          • Paolo Calabrò, MD
      • Catanzaro, Italy, 88100
        • Recruiting
        • University Magna Graecia of Catanzaro
        • Contact:
          • Ciro Indolfi, MD
      • Eboli, Italy, 84025
        • Recruiting
        • Presidio Ospedaliero Maria SS Addolorata
        • Contact:
          • Angelo Catalano, MD
      • Foggia, Italy, 71122
        • Recruiting
        • Policlinico Riuniti Foggia
        • Contact:
          • Natale Brunetti, MD
      • Genova, Italy, 16126
        • Recruiting
        • Universita degli Studi di Genova
        • Contact:
          • Italo Porto, MD
      • Lecce, Italy, 73100
        • Recruiting
        • Ospedale di Lecce
        • Contact:
          • Giuseppe Colonna, MD
      • Messina, Italy, 98122
        • Recruiting
        • Università degli Studi di Messina
        • Contact:
          • Giuseppe Andò, MD
      • Milan, Italy, 20162
        • Recruiting
        • ASST Grande Ospedale Metropolitano Niguarda
        • Contact:
          • Piera Merlini, MD
        • Principal Investigator:
          • Alessandro Maloberti, MD
      • Milan, Italy, 20122
        • Recruiting
        • Policlinico di Milano Ospedale Maggiore - Fondazione IRCCS Ca' Granda
        • Contact:
          • Stefano Carugo, MD
      • Napoli, Italy, 80131
        • Recruiting
        • AORN dei Colli - Ospedale monaldi
        • Contact:
          • Mario Crisci, MD
      • Napoli, Italy, 80131
        • Recruiting
        • Federico II University of Naples, Department of Advanced Biomedical Sciences
        • Contact:
          • Pasquale Perrone Filardi, MD
      • Napoli, Italy, 80131
        • Recruiting
        • Federico II University of Naples, Department of Translational Medical Sciences
        • Contact:
          • Francesco Giallauria, MD
      • Napoli, Italy, 80131
        • Recruiting
        • University of Naples Federico II, Department of Clinical Medicine and Surgery
        • Contact:
          • Gabriella Iannuzzo, MD
      • Novara, Italy, 28100
        • Recruiting
        • Azienda Ospedaliero-Universitaria "Maggiore della Carità"
        • Contact:
          • Giuseppe Patti, MD
      • Parma, Italy, 43126
        • Recruiting
        • Azienda Ospedaliero-Univeristaria di Parma
        • Contact:
          • Giampaolo Niccoli, MD
      • Pescara, Italy, 65124
        • Recruiting
        • Presidio Ospedaliero Pescara
        • Contact:
          • Leonardo Paloscia, MD
      • Rivoli, Italy, 10098
        • Recruiting
        • Ospedale di Rivoli
        • Contact:
          • Fernando Varbella, MD
        • Principal Investigator:
          • Antonella Corleto, MD
      • Roma, Italy, 00169
        • Recruiting
        • Policlinico Casilino
        • Contact:
          • Leonardo Calò, MD
      • Roma, Italy, 00133
        • Recruiting
        • Policlinico Tor Vergata
        • Contact:
          • Saverio Muscoli, MD
      • Roma, Italy, 00152
        • Recruiting
        • Azienda Ospedaliera San Camillo-Forlanini
        • Contact:
          • Leonardo De Luca, MD
      • Roma, Italy, 00185
        • Withdrawn
        • Sapienza University of Rome
      • Salerno, Italy, 84131
        • Recruiting
        • Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
        • Contact:
          • Gennaro Galasso, MD
      • Sassari, Italy, 07100
        • Recruiting
        • Ospedale SS Annunziata A.O.U.
        • Contact:
          • Gavino Casu, MD
      • Siena, Italy, 53100
        • Recruiting
        • University of Siena
        • Contact:
          • Matteo Cameli, MD
      • Torino, Italy, 10128
        • Recruiting
        • Azienda Ospedaliera Ordine Mauriziano Torino
        • Contact:
          • Giuseppe Musumeci, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Patients under PCSK9 inhibitor treatment.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1
Subjects with hyperlipidaemia under PCSK9 inhibitors treatment (Repatha/Praulent).
Drug: Repatha (evolocumab); Praluent (alirocumab)
Dosage form: Injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
every 6 months
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.
every 6 months
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).
every 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Safety will be evaluated in terms of adverse reactions or intolerance to the drug.
every 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 264/20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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