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

Evaluation of adherence, persistence and efficacy of treatment with PCSK9 inhibitors in a real-life Italian population.

Study Overview

• Status: Recruiting
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Repatha (evolocumab); Praluent (alirocumab)

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: 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
    • Università degli Studi di Genova
    • Contact: Italo Porto, MD
  • Lecce, Italy, 73100
    • Recruiting
    • Ospedale di Lecce
    • Contact: Giuseppe Colonna, MD
  • Messina, Italy, 98122
    • Recruiting
    • Universita degli Studi di Messina
    • Contact: Giuseppe Andò, MD
  • Milano, Italy, 20162
    • Recruiting
    • ASST Grande Ospedale Metropolitano Niguarda
    • Contact: Piera Merlini, MD
    • Principal Investigator: Alessandro Maloberti, MD
  • Milano, 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

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: 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

How is the study designed?

Design Details

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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).	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.	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).	6 months

Secondary Outcome Measures

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.	Safety will be evaluated in terms of adverse reactions or intolerance to the drug.	6 months

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2020
• Primary Completion (Estimated): March 7, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Protease Inhibitors; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Serine Proteinase Inhibitors; PCSK9 Inhibitors; Evolocumab; Alirocumab
• Other Study ID 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