Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy
AT-TARGET-IT
Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy
1 other identifier
observational
5,000
1 country
27
Brief Summary
Evaluation of adherence, persistence and efficacy of treatment with PCSK9 inhibitors in a real-life Italian population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Longer than P75 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2022
CompletedFirst Submitted
Initial submission to the registry
June 20, 2022
CompletedFirst Posted
Study publicly available on registry
June 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2030
ExpectedJanuary 22, 2026
January 1, 2026
1.9 years
June 20, 2022
January 21, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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).
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.
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).
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.
every 6 months
Study Arms (1)
Group 1
Subjects with hyperlipidaemia under PCSK9 inhibitors treatment (Repatha/Praulent).
Interventions
Eligibility Criteria
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.
You may qualify if:
- Patients under PCSK9 inhibitor treatment.
You may not qualify if:
- Age \< 18 years o \> 80 years;
- Patients who refuse to participate and to sign informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Ospedali dell'Ovest Vicentino
Arzignano, 36071, Italy
University of Bari Aldo Moro
Bari, 70121, Italy
University of Campania Luigi Vanvitelli
Caserta, 81100, Italy
University Magna Graecia of Catanzaro
Catanzaro, 88100, Italy
Presidio Ospedaliero Maria SS Addolorata
Eboli, 84025, Italy
Policlinico Riuniti Foggia
Foggia, 71122, Italy
Università degli Studi di Genova
Genova, 16126, Italy
Ospedale di Lecce
Lecce, 73100, Italy
Università degli Studi di Messina
Messina, 98122, Italy
Policlinico di Milano Ospedale Maggiore - Fondazione IRCCS Ca' Granda
Milan, 20122, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
AORN dei Colli - Ospedale monaldi
Naples, 80131, Italy
Federico II University of Naples, Department of Advanced Biomedical Sciences
Naples, 80131, Italy
Federico II University of Naples, Department of Translational Medical Sciences
Naples, 80131, Italy
University of Naples Federico II, Department of Clinical Medicine and Surgery
Naples, 80131, Italy
Azienda Ospedaliero-Universitaria "Maggiore della Carità"
Novara, 28100, Italy
Azienda Ospedaliero-Univeristaria di Parma
Parma, 43126, Italy
Presidio Ospedaliero Pescara
Pescara, 65124, Italy
Ospedale di Rivoli
Rivoli, 10098, Italy
Policlinico Tor Vergata
Roma, 00133, Italy
Azienda Ospedaliera San Camillo-Forlanini
Roma, 00152, Italy
Policlinico Casilino
Roma, 00169, Italy
Sapienza University of Rome
Roma, 00185, Italy
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
Salerno, 84131, Italy
Ospedale SS Annunziata A.O.U.
Sassari, 07100, Italy
University of Siena
Siena, 53100, Italy
Azienda Ospedaliera Ordine Mauriziano Torino
Torino, 10128, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
June 20, 2022
First Posted
June 24, 2022
Study Start
March 7, 2020
Primary Completion
January 30, 2022
Study Completion (Estimated)
March 31, 2030
Last Updated
January 22, 2026
Record last verified: 2026-01