Adherence, persistence, and real-life effectiveness of alirocumab 300 mg for people with high cholesterol in Italy

Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy - The ALINET Registry

This project will test whether alirocumab 300 mg helps people with high cholesterol in Italy stick with their treatment and lower their cholesterol when used in routine care.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Federico II University (Academic / other)
• Drugs / interventions: alirocumab
• Locations: 1 site (Naples, Napoli)
• Trial ID: NCT07375225 on ClinicalTrials.gov

What this trial studies

This is an observational, real-world study of patients in Italy who are being treated with alirocumab 300 mg, tracking how well they adhere to and persist with therapy and how their cholesterol levels respond. Investigators will collect clinical data and prescription/visit records from participating patients treated at the enrolling center. Eligible participants are adults aged 18–80 who are already receiving alirocumab 300 mg and provide informed consent. The design is non-randomized and reflects routine clinical practice rather than a controlled interventional protocol.

Who should consider this trial

Good fit: Ideal participants are adults aged 18–80 with hypercholesterolaemia who are currently being treated with alirocumab 300 mg and can give informed consent.

Not a fit: Patients under 18 or over 80, those not on alirocumab 300 mg, or those who refuse consent are not expected to benefit from participating.

Why it matters

Potential benefit: If successful, the results could show that alirocumab 300 mg improves treatment persistence and lowers LDL cholesterol in routine clinical care, helping clinicians make informed prescribing choices.

How similar studies have performed: Randomized trials have demonstrated that alirocumab lowers LDL cholesterol and can reduce cardiovascular events, but there are fewer real-world observational reports focused specifically on adherence and persistence with the 300 mg dose in Italian practice.

Eligibility criteria

Inclusion Criteria:

\- Patients under alirocumab 300mg treatment.

Exclusion Criteria:

* Age \< 18 years o \> 80 years;
* Patients who refuse to participate and to sign informed consent.

Where this trial is running

Naples, Napoli

• Federico II University of Naples, Department of Advanced Biomedical Sciences — Naples, Napoli, Italy (Recruiting)

Study contacts

• Study coordinator: Pasquale Perrone Filardi

Conditions Hypercholesterolaemia