Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy

NCT ID: NCT05430828

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-07

Study Completion Date

2030-03-31

Brief Summary

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

Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Group 1

Subjects with hyperlipidaemia under PCSK9 inhibitors treatment (Repatha/Praulent).

Repatha (evolocumab); Praluent (alirocumab)

Intervention Type DRUG

Dosage form: Injection

Interventions

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Repatha (evolocumab); Praluent (alirocumab)

Dosage form: Injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Pasquale Perrone Filardi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ospedali dell'Ovest Vicentino

Arzignano, , Italy

Site Status RECRUITING

University of Bari Aldo Moro

Bari, , Italy

Site Status RECRUITING

University of Campania Luigi Vanvitelli

Caserta, , Italy

Site Status RECRUITING

University Magna Graecia of Catanzaro

Catanzaro, , Italy

Site Status RECRUITING

Presidio Ospedaliero Maria SS Addolorata

Eboli, , Italy

Site Status RECRUITING

Policlinico Riuniti Foggia

Foggia, , Italy

Site Status RECRUITING

Università degli Studi di Genova

Genova, , Italy

Site Status RECRUITING

Ospedale di Lecce

Lecce, , Italy

Site Status RECRUITING

Università degli Studi di Messina

Messina, , Italy

Site Status RECRUITING

Policlinico di Milano Ospedale Maggiore - Fondazione IRCCS Ca' Granda

Milan, , Italy

Site Status RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Site Status RECRUITING

AORN dei Colli - Ospedale monaldi

Napoli, , Italy

Site Status RECRUITING

Federico II University of Naples, Department of Advanced Biomedical Sciences

Napoli, , Italy

Site Status RECRUITING

Federico II University of Naples, Department of Translational Medical Sciences

Napoli, , Italy

Site Status RECRUITING

University of Naples Federico II, Department of Clinical Medicine and Surgery

Napoli, , Italy

Site Status RECRUITING

Azienda Ospedaliero-Universitaria "Maggiore della Carità"

Novara, , Italy

Site Status RECRUITING

Azienda Ospedaliero-Univeristaria di Parma

Parma, , Italy

Site Status RECRUITING

Presidio Ospedaliero Pescara

Pescara, , Italy

Site Status RECRUITING

Ospedale di Rivoli

Rivoli, , Italy

Site Status RECRUITING

Policlinico Tor Vergata

Roma, , Italy

Site Status RECRUITING

Azienda Ospedaliera San Camillo-Forlanini

Roma, , Italy

Site Status RECRUITING

Policlinico Casilino

Roma, , Italy

Site Status RECRUITING

Sapienza University of Rome

Roma, , Italy

Site Status WITHDRAWN

Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona

Salerno, , Italy

Site Status RECRUITING

Ospedale SS Annunziata A.O.U.

Sassari, , Italy

Site Status RECRUITING

University of Siena

Siena, , Italy

Site Status RECRUITING

Azienda Ospedaliera Ordine Mauriziano Torino

Torino, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Pasquale Perrone Filardi, MD

Role: CONTACT

+390817462224

Facility Contacts

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Claudio Bilato, MD

Role: primary

Marco Matteo Ciccone, MD

Role: primary

Paolo Calabrò, MD

Role: primary

Ciro Indolfi, MD

Role: primary

Angelo Catalano, MD

Role: primary

Natale Brunetti, MD

Role: primary

Italo Porto, MD

Role: primary

Giuseppe Colonna, MD

Role: primary

Giuseppe Andò, MD

Role: primary

Stefano Carugo, MD

Role: primary

Piera Merlini, MD

Role: primary

Mario Crisci, MD

Role: primary

Pasquale Perrone Filardi, MD

Role: primary

Francesco Giallauria, MD

Role: primary

Gabriella Iannuzzo, MD

Role: primary

Giuseppe Patti, MD

Role: primary

Giampaolo Niccoli, MD

Role: primary

Leonardo Paloscia, MD

Role: primary

Fernando Varbella, MD

Role: primary

Saverio Muscoli, MD

Role: primary

Leonardo De Luca, MD

Role: primary

Leonardo Calò, MD

Role: primary

Gennaro Galasso, MD

Role: primary

Gavino Casu, MD

Role: primary

Matteo Cameli, MD

Role: primary

Giuseppe Musumeci, MD

Role: primary

Other Identifiers

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264/20

Identifier Type: -

Identifier Source: org_study_id

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