Clinical trial NCT05430828: Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy
Official title: Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypercholesterolemia
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population includes patients from Italy, who have received PCSK9 inhibitor as part of routine clinical management of their hyperlipidaemia for at least 6 months at time of enrollment, based on national reimbursement criteria.

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


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.

Primary outcomes:
measure: Description of adherence of treatment with PCSK9 inhibitors in a real-life Italian population.
timeFrame: 6 months
measure: Description of persistence of treatment with PCSK9 inhibitors in a real-life Italian population.
timeFrame: 6 months
measure: Description of efficacy of treatment with PCSK9 inhibitors in a real-life Italian population.
timeFrame: 6 months
Secondary outcomes:
measure: Description of adherence, efficacy and safety of treatment with PCSK9 inhibitors in a real-life Italian population general and divided into subgroups.
timeFrame: 6 months
Other outcomes:
Locations:
city: Arzignano
country: Italy
facility: Ospedali dell'Ovest Vicentino
city: Bari
country: Italy
facility: University of Bari Aldo Moro
city: Caserta
country: Italy
facility: University of Campania Luigi Vanvitelli
city: Catanzaro
country: Italy
facility: University Magna Graecia of Catanzaro
city: Eboli
country: Italy
facility: Presidio Ospedaliero Maria SS Addolorata
city: Foggia
country: Italy
facility: Policlinico Riuniti Foggia
city: Genova
country: Italy
facility: Università degli Studi di Genova
city: Lecce
country: Italy
facility: Ospedale di Lecce
city: Messina
country: Italy
facility: Università degli Studi di Messina
city: Milano
country: Italy
facility: Policlinico di Milano Ospedale Maggiore - Fondazione IRCCS Ca' Granda
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Napoli
country: Italy
facility: AORN dei Colli - Ospedale monaldi
city: Napoli
country: Italy
facility: Federico II University of Naples, Department of Advanced Biomedical Sciences
city: Napoli
country: Italy
facility: Federico II University of Naples, Department of Translational Medical Sciences
city: Napoli
country: Italy
facility: University of Naples Federico II, Department of Clinical Medicine and Surgery
city: Novara
country: Italy
facility: Azienda Ospedaliero-Universitaria "Maggiore della Carità"
city: Parma
country: Italy
facility: Azienda Ospedaliero-Univeristaria di Parma
city: Pescara
country: Italy
facility: Presidio Ospedaliero Pescara
city: Rivoli
country: Italy
facility: Ospedale di Rivoli
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo-Forlanini
city: Roma
country: Italy
facility: Policlinico Casilino
city: Roma
country: Italy
facility: Sapienza University of Rome
city: Salerno
country: Italy
facility: Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
city: Sassari
country: Italy
facility: Ospedale SS Annunziata A.O.U.
city: Siena
country: Italy
facility: University of Siena
city: Torino
country: Italy
facility: Azienda Ospedaliera Ordine Mauriziano Torino
Study officials:
References: