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NCT Number: NCT05430828

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

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

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedali dell'Ovest Vicentino, Arzignano, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Repatha (evolocumab); Praluent (alirocumab)

Drug

Dosage form: Injection

Primary outcomes

  1. 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).

  2. 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.

  3. 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).

Secondary outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pasquale Perrone Filardi, MD

CONTACT

[email protected]

+390817462224

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Acronym: AT-TARGET-IT

Important dates

Study start
2020
Primary completion
2022
Study completion
2030
First posted
Jun 24, 2022
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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