Clinical trial Recruiting at 26 sites Observational Ages 18 to 80

Evaluating the effectiveness of PCSK9 inhibitors for cholesterol management in Italy

Official title: Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy

Run by Federico II University · NCT05430828 · Data updated 2026-11-12

This study is testing how well people in Italy stick to using PCSK9 inhibitors like Repatha and Praluent to manage their cholesterol levels in everyday life.

More Hypercholesterolemia trials

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment5000 (estimated)
SponsorFederico II University
Academic / other
Locations27 sites (Arzignano and 26 other locations)
StatusRecruiting
StartedMarch 7, 2020
Main results expectedJanuary 30, 2022
Study endsMarch 31, 2030
Registry record updatedJanuary 22, 2026
Trial IDNCT05430828 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients currently receiving treatment with PCSK9 inhibitors.

Probably not a fit

Patients under 18 or over 80 years old, as well as those who refuse to participate, will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study assesses how well patients adhere to and persist with treatment using PCSK9 inhibitors, specifically Repatha and Praluent, in a real-life setting across various locations in Italy. The study aims to gather data on the efficacy of these treatments in managing hypercholesterolemia among the Italian population. By monitoring patient outcomes and treatment adherence, the study seeks to provide insights into the real-world effectiveness of these medications.

Why it matters

Potential benefit: If successful, this study could enhance understanding of PCSK9 inhibitors' effectiveness, leading to improved cholesterol management for patients.

How similar studies have gone: Other studies have shown positive outcomes with PCSK9 inhibitors, indicating that this approach is supported by existing evidence.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Ospedali dell'Ovest Vicentino
    Arzignano, Italy
    Recruiting
  • University of Bari Aldo Moro
    Bari, Italy
    Recruiting
  • University of Campania Luigi Vanvitelli
    Caserta, Italy
    Recruiting
  • University Magna Graecia of Catanzaro
    Catanzaro, Italy
    Recruiting
  • Presidio Ospedaliero Maria SS Addolorata
    Eboli, Italy
    Recruiting
  • Policlinico Riuniti Foggia
    Foggia, Italy
    Recruiting
Show 21 more locations
  • Università degli Studi di Genova
    Genova, Italy
    Recruiting
  • Ospedale di Lecce
    Lecce, Italy
    Recruiting
  • Università degli Studi di Messina
    Messina, Italy
    Recruiting
  • Policlinico di Milano Ospedale Maggiore - Fondazione IRCCS Ca' Granda
    Milan, Italy
    Recruiting
  • ASST Grande Ospedale Metropolitano Niguarda
    Milan, Italy
    Recruiting
  • AORN dei Colli - Ospedale monaldi
    Naples, Italy
    Recruiting
  • Federico II University of Naples, Department of Advanced Biomedical Sciences
    Naples, Italy
    Recruiting
  • Federico II University of Naples, Department of Translational Medical Sciences
    Naples, Italy
    Recruiting
  • University of Naples Federico II, Department of Clinical Medicine and Surgery
    Naples, Italy
    Recruiting
  • Azienda Ospedaliero-Universitaria "Maggiore della Carità"
    Novara, Italy
    Recruiting
  • Azienda Ospedaliero-Univeristaria di Parma
    Parma, Italy
    Recruiting
  • Presidio Ospedaliero Pescara
    Pescara, Italy
    Recruiting
  • Ospedale di Rivoli
    Rivoli, Italy
    Recruiting
  • Policlinico Tor Vergata
    Roma, Italy
    Recruiting
  • Azienda Ospedaliera San Camillo-Forlanini
    Roma, Italy
    Recruiting
  • Policlinico Casilino
    Roma, Italy
    Recruiting
  • Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
    Salerno, Italy
    Recruiting
  • Ospedale SS Annunziata A.O.U.
    Sassari, Italy
    Recruiting
  • University of Siena
    Siena, Italy
    Recruiting
  • Azienda Ospedaliera Ordine Mauriziano Torino
    Torino, Italy
    Recruiting
  • Sapienza University of Rome
    Roma, Italy
    Withdrawn

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.