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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | Federico II University Academic / other |
| Locations | 27 sites (Arzignano and 26 other locations) |
| Status | Recruiting |
| Started | March 7, 2020 |
| Main results expected | January 30, 2022 |
| Study ends | March 31, 2030 |
| Registry record updated | January 22, 2026 |
| Trial ID | NCT05430828 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
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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
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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
- Study coordinator: Pasquale Perrone Filardi, MD
- Email: fpperron@unina.it
- Phone: +390817462224
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
VERVE-102 for adults with or at high risk for heart disease
This study tests whether VERVE-102 can lower bad cholesterol (LDL-C) compared with a placebo in adults with plaque buildup or high risk for it.
-
Enlicitide (MK-0616) for adults with high cholesterol in India
This study tests whether enlicitide helps lower bad cholesterol (LDL-C) compared with placebo in adults with hyperlipidemia/hypercholesterolemia.
-
Pemafibrate in people with high cholesterol not fully controlled by statins
This study tests whether taking Pemafibrate at 0.2 mg or 0.4 mg daily for 12 weeks helps people with high cholesterol who still don’t respond well to statins, compared with a placebo.
-
Dual PCSK9 Inhibition in secondary prevention for high LDL-C with statin intolerance
This study tests whether combining inclisiran and alirocumab lowers LDL cholesterol better than either drug alone in people with ASCVD who can’t tolerate statins.
-
Moderate-Intensity Statin + Ezetimibe vs High-Intensity Statin in CKD with ASCVD
In adults with chronic kidney disease and established cardiovascular disease, this study tests whether a moderate-intensity statin plus ezetimibe can match the benefits of a high-intensity statin alone over three years.
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Corn oil versus avocado oil effects on cardiometabolic risk factors
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.