Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy
For Condition: Hypercholesterolemia
ID: NCT05430828
Horizon Patient Guidance Summary
Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:
How it’s taken
Injections / IV Shots
Expected Availability Horizon
General pipeline timeline
StageGeneral evaluation study exploring treatment methods.
EligibleThis study is looking exclusively for patients diagnosed with the condition.
About This Clinical Trial
Evaluation of adherence, persistence and efficacy of treatment with PCSK9 inhibitors in a real-life Italian population.
Study Timeline & Quick Facts
Trial Status
Open — Looking for Participants
Total Target Enrollment
5K patients (Estimated)
Study Start Date
2020-03-07
Est. Primary Completion
2022-01-30
Tested Drugs & Treatment Groups
DRUGRepatha (evolocumab); Praluent (alirocumab)
Dosage form: Injection
Treatment Arms Description
ARM GROUPGroup 1
Subjects with hyperlipidaemia under PCSK9 inhibitors treatment (Repatha/Praulent).
Can I Join This Study?
Suitable For
Everyone welcome
Ages Welcome
Between 18 Years and 80 Years
Full Criteria Checklist
Who Can Join
Patients under PCSK9 inhibitor treatment.
Who Cannot Join
Age \< 18 years o \> 80 years;
Patients who refuse to participate and to sign informed consent.
What is this Study Measuring?
Primary Outcome Measures
Description of adherence of treatment with PCSK9 inhibitors in a real-life Italian population. — Time Frame: every 6 months
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).
Description of persistence of treatment with PCSK9 inhibitors in a real-life Italian population. — Time Frame: every 6 months
Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment.
Description of efficacy of treatment with PCSK9 inhibitors in a real-life Italian population. — Time Frame: every 6 months
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).
View 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
Safety will be evaluated in terms of adverse reactions or intolerance to the drug.
Where to Participate
This trial is recruiting at 27 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 27 Facilities & Contact Sites
Ospedali dell'Ovest Vicentino
Arzignano, Italy
Status: Open
University of Bari Aldo Moro
Bari, Italy
Status: Open
University of Campania Luigi Vanvitelli
Caserta, Italy
Status: Open
University Magna Graecia of Catanzaro
Catanzaro, Italy
Status: Open
Presidio Ospedaliero Maria SS Addolorata
Eboli, Italy
Status: Open
Policlinico Riuniti Foggia
Foggia, Italy
Status: Open
Università degli Studi di Genova
Genova, Italy
Status: Open
Ospedale di Lecce
Lecce, Italy
Status: Open
Università degli Studi di Messina
Messina, Italy
Status: Open
Policlinico di Milano Ospedale Maggiore - Fondazione IRCCS Ca' Granda
Milan, Italy
Status: Open
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Status: Open
AORN dei Colli - Ospedale monaldi
Naples, Italy
Status: Open
Federico II University of Naples, Department of Advanced Biomedical Sciences
Naples, Italy
Status: Open
Federico II University of Naples, Department of Translational Medical Sciences
Naples, Italy
Status: Open
University of Naples Federico II, Department of Clinical Medicine and Surgery
Naples, Italy
Status: Open
Azienda Ospedaliero-Universitaria "Maggiore della Carità"
Novara, Italy
Status: Open
Azienda Ospedaliero-Univeristaria di Parma
Parma, Italy
Status: Open
Presidio Ospedaliero Pescara
Pescara, Italy
Status: Open
Ospedale di Rivoli
Rivoli, Italy
Status: Open
Policlinico Tor Vergata
Roma, Italy
Status: Open
Azienda Ospedaliera San Camillo-Forlanini
Roma, Italy
Status: Open
Policlinico Casilino
Roma, Italy
Status: Open
Sapienza University of Rome
Roma, Italy
Status: Withdrawn
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
Want to apply or inquire about joining this study? Fill out this simple questionnaire, and our assistant will instantly generate a professional email draft you can copy and send to the central contact coordinator listed above!
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Subject: Inquiry about clinical trial enrollment: NCT05430828 - Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy
Dear Study Coordinator / Research Team,
I hope this message finds you well.
My name is [Your Name], and I am writing to express my strong interest in participating in the clinical trial titled "Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy" (NCT ID: NCT05430828).
I am [Age] years old and have been diagnosed with Hypercholesterolemia. I have reviewed the eligibility criteria for this study on Med Code Info and believe I may be a suitable candidate.
Could you please let me know if this study is actively enrolling patients at any site near my location, and what the next steps are to undergo screening?
Thank you for your time and research efforts.
Warm regards,
[Your Name]
View Official Medical/Scientific Title
Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy
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Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy — NCT05430828 | Med-Code