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Massive italian study tracks Real-World use of Cholesterol-Lowering injections

NCT ID NCT05430828

Knowledge-focused Sponsor: Federico II University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is following 5,000 Italian patients who are taking PCSK9 inhibitor injections (Repatha or Praluent) for high cholesterol. Researchers want to see how consistently patients take their medication and how well it lowers their LDL cholesterol in real life, not just in a lab. The study will also track side effects and look at differences by age, sex, and other factors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PCSK9 inhibitors (evolocumab and alirocumab) given as injections
What this could lead to
If successful, this study could show how well these cholesterol-lowering drugs work in everyday use and help doctors improve treatment plans.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may not apply outside Italy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 5,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2020

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Hypercholesterolemia hyperlipidemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypercholesterolemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AORN dei Colli - Ospedale monaldi

    RECRUITING

    Naples, 80131, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

  • Azienda Ospedaliera Ordine Mauriziano Torino

    RECRUITING

    Torino, 10128, Italy

  • Azienda Ospedaliera San Camillo-Forlanini

    RECRUITING

    Roma, 00152, Italy

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

    RECRUITING

    Salerno, 84131, Italy

  • Azienda Ospedaliero-Univeristaria di Parma

    RECRUITING

    Parma, 43126, Italy

  • Azienda Ospedaliero-Universitaria "Maggiore della Carità"

    RECRUITING

    Novara, 28100, Italy

  • Federico II University of Naples, Department of Advanced Biomedical Sciences

    RECRUITING

    Naples, 80131, Italy

  • Federico II University of Naples, Department of Translational Medical Sciences

    RECRUITING

    Naples, 80131, Italy

  • Ospedale SS Annunziata A.O.U.

    RECRUITING

    Sassari, 07100, Italy

  • Ospedale di Lecce

    RECRUITING

    Lecce, 73100, Italy

  • Ospedale di Rivoli

    RECRUITING

    Rivoli, 10098, Italy

  • Ospedali dell'Ovest Vicentino

    RECRUITING

    Arzignano, 36071, Italy

  • Policlinico Casilino

    RECRUITING

    Roma, 00169, Italy

  • Policlinico Riuniti Foggia

    RECRUITING

    Foggia, 71122, Italy

  • Policlinico Tor Vergata

    RECRUITING

    Roma, 00133, Italy

  • Policlinico di Milano Ospedale Maggiore - Fondazione IRCCS Ca' Granda

    RECRUITING

    Milan, 20122, Italy

  • Presidio Ospedaliero Maria SS Addolorata

    RECRUITING

    Eboli, 84025, Italy

  • Presidio Ospedaliero Pescara

    RECRUITING

    Pescara, 65124, Italy

  • Sapienza University of Rome

    WITHDRAWN

    Roma, 00185, Italy

  • University Magna Graecia of Catanzaro

    RECRUITING

    Catanzaro, 88100, Italy

  • University of Bari Aldo Moro

    RECRUITING

    Bari, 70121, Italy

  • University of Campania Luigi Vanvitelli

    RECRUITING

    Caserta, 81100, Italy

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

    RECRUITING

    Naples, 80131, Italy

  • University of Siena

    RECRUITING

    Siena, 53100, Italy

  • Università degli Studi di Genova

    RECRUITING

    Genova, 16126, Italy

  • Università degli Studi di Messina

    RECRUITING

    Messina, 98122, Italy

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