Evaluating the effectiveness of PCSK9 inhibitors for cholesterol management in Italy

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

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.

Quick facts

• Study type: Observational
• Enrollment: 5000 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Federico II University (Academic / other)
• Locations: 27 sites (Arzignano and 26 other locations)
• Trial ID: NCT05430828 on ClinicalTrials.gov

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.

Who should consider this trial

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

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.

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

Eligibility 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 this trial is running

Arzignano and 26 other locations

• 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)
• 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)
• Sapienza University of Rome — Roma, Italy (Withdrawn)
• 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)

Study contacts

• Study coordinator: Pasquale Perrone Filardi, MD

Conditions Hypercholesterolemia