Actively Recruiting

Age: 18Years - 80Years
All Genders
ID05430828

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

Led by Federico II University · Updated on 2026-01-22

5000

Participants Needed

27

Research Sites

426 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the adherence, persistence, and effectiveness of PCSK9 inhibitors in treating hypercholesterolemia among a real-life Italian population. This observational study focuses on patients receiving these medications to better understand treatment patterns and outcomes outside of controlled clinical trials. Participants in this study are patients with hyperlipidemia who are currently treated with PCSK9 inhibitors, specifically Repatha (evolocumab) or Praluent (alirocumab), administered by injection. The study observes these patients without altering their treatment, collecting data over time to assess how well patients stick to their treatment plans and how effective the medications are. During the study, researchers will gather information every six months about treatment adherence, persistence, and efficacy. They will also monitor safety and analyze results within different patient subgroups. Participation includes regular assessments of medication use and health outcomes, with the study continuing until March 31, 2030.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients under PCSK9 inhibitor treatment.
Not Eligible

You will not qualify if you...

  • Age under 18 years or over 80 years.
  • Patients who refuse to participate and to sign informed consent.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - Up to 8 years

Participants who are under treatment with PCSK9 inhibitors are observed to evaluate adherence, persistence, and efficacy.

Visits every 6 months

Trial Site Locations

Total: 27 locations

1

Ospedali dell'Ovest Vicentino

Arzignano, Italy, 36071

Actively Recruiting

2

University of Bari Aldo Moro

Bari, Italy, 70121

Actively Recruiting

3

University of Campania Luigi Vanvitelli

Caserta, Italy, 81100

Actively Recruiting

4

University Magna Graecia of Catanzaro

Catanzaro, Italy, 88100

Actively Recruiting

5

Presidio Ospedaliero Maria SS Addolorata

Eboli, Italy, 84025

Actively Recruiting

6

Policlinico Riuniti Foggia

Foggia, Italy, 71122

Actively Recruiting

7

Università degli Studi di Genova

Genova, Italy, 16126

Actively Recruiting

8

Ospedale di Lecce

Lecce, Italy, 73100

Actively Recruiting

9

Università degli Studi di Messina

Messina, Italy, 98122

Actively Recruiting

10

Policlinico di Milano Ospedale Maggiore - Fondazione IRCCS Ca' Granda

Milan, Italy, 20122

Actively Recruiting

11

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy, 20162

Actively Recruiting

12

AORN dei Colli - Ospedale monaldi

Naples, Italy, 80131

Actively Recruiting

13

Federico II University of Naples, Department of Advanced Biomedical Sciences

Naples, Italy, 80131

Actively Recruiting

14

Federico II University of Naples, Department of Translational Medical Sciences

Naples, Italy, 80131

Actively Recruiting

15

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

Naples, Italy, 80131

Actively Recruiting

16

Azienda Ospedaliero-Universitaria "Maggiore della Carità"

Novara, Italy, 28100

Actively Recruiting

17

Azienda Ospedaliero-Univeristaria di Parma

Parma, Italy, 43126

Actively Recruiting

18

Presidio Ospedaliero Pescara

Pescara, Italy, 65124

Actively Recruiting

19

Ospedale di Rivoli

Rivoli, Italy, 10098

Actively Recruiting

20

Policlinico Tor Vergata

Roma, Italy, 00133

Actively Recruiting

21

Azienda Ospedaliera San Camillo-Forlanini

Roma, Italy, 00152

Actively Recruiting

22

Policlinico Casilino

Roma, Italy, 00169

Actively Recruiting

23

Sapienza University of Rome

Roma, Italy, 00185

Withdrawn

24

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

Salerno, Italy, 84131

Actively Recruiting

25

Ospedale SS Annunziata A.O.U.

Sassari, Italy, 07100

Actively Recruiting

26

University of Siena

Siena, Italy, 53100

Actively Recruiting

27

Azienda Ospedaliera Ordine Mauriziano Torino

Torino, Italy, 10128

Actively Recruiting

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Research Team

P

Pasquale Perrone Filardi, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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