Recruiting NCT05430828
Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Repatha (evolocumab); Praluent (alirocumab).
- Who it may be relevant to
- Registry conditions: Hypercholesterolemia. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy
Overview
Evaluation of adherence, persistence and efficacy of treatment with PCSK9 inhibitors in a real-life Italian population.
Interventions
- Drug Repatha (evolocumab); Praluent (alirocumab)
Dosage form: Injection
Primary outcome measures
- Description of adherence of treatment with PCSK9 inhibitors in a real-life Italian population. [Time frame: every 6 months]
- Description of persistence of treatment with PCSK9 inhibitors in a real-life Italian population. [Time frame: every 6 months]
- Description of efficacy of treatment with PCSK9 inhibitors in a real-life Italian population. [Time frame: every 6 months]
Secondary outcome measures (1)
- Description of adherence, efficacy and safety of treatment with PCSK9 inhibitors in a real-life Italian population general and divided into subgroups. [Time frame: every 6 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Italy · 27 centers
- Ospedali dell'Ovest Vicentino — Arzignano
- University of Bari Aldo Moro — Bari
- University of Campania Luigi Vanvitelli — Caserta
- University Magna Graecia of Catanzaro — Catanzaro
- Presidio Ospedaliero Maria SS Addolorata — Eboli
- Policlinico Riuniti Foggia — Foggia
- Università degli Studi di Genova — Genova
- Ospedale di Lecce — Lecce
- … and 19 more centers
Identifiers
NCT: NCT05430828 · 264/20