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

Hypercholesterolemia Clinical Trial

— AT-TARGET-IT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05430828
• Other study ID #: 264/20
• Status: Recruiting
• Start date: March 7, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: September 2023
• Source: Federico II University
• Contact: Pasquale Perrone Filardi, MD
• Phone: +390817462224
• Email: fpperron[@]unina.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 31, 2024
• Est. primary completion date: March 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Repatha (evolocumab); Praluent (alirocumab)
Dosage form: Injection

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of adherence of treatment with PCSK9 inhibitors in a real-life Italian population.	Adherence will be assessed in terms of Medical Possession Ratio (MPR) which is defined as the ratio between the treatment units dispensed during the treatment period and the duration of the treatment period itself. MPR will be calculated as overall MPR (mean and median value), MPR by type of prevention (primary and secondary), MPR by type of antiPCSK9 inhibitor (alirocumab vs. evolocumab), MPR by type of background therapy (statin yes, statin no) , MPR by demographic variables (age, sex, geographic origin, basal LDL levels), MPR by type of prescriber (hospital or territorial).	6 months
Primary	Description of persistence of treatment with PCSK9 inhibitors in a real-life Italian population.	Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment.	6 months
Primary	Description of efficacy of treatment with PCSK9 inhibitors in a real-life Italian population.	Efficacy of treatment will be evaluated as a change in the LDL (deltaLDL) value from the start of treatment (percentage and absolute value). The deltaLDL will be calculated as an overall (mean and median value), by type of prevention (primary and secondary), by type of antiPCSK9 inhibitor (alirocumab vs. evolocumab), by type of basic therapy (statin yes, statin no), by demographic variables (age, sex, geographic origin, basal LDL levels), by type of prescriber (hospital or territorial).	6 months
Secondary	Description of adherence, efficacy and safety of treatment with PCSK9 inhibitors in a real-life Italian population general and divided into subgroups.	Safety will be evaluated in terms of adverse reactions or intolerance to the drug.	6 months