Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy
- Registration Number
- NCT06287177
- Lead Sponsor
- Federico II University
- Brief Summary
Evaluation of adherence, persistence and efficacy of treatment with Inclisiran in a real-life Italian population
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Patients under Inclisiran treatment
- Age < 18 years o > 80 years
- Patients who refuse to participate and to sign informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subjects with hyperlipidaemia under Inclisiran treatment Inclisiran -
- Primary Outcome Measures
Name Time Method Description of efficacy of treatment with Inclisiran in a real-life Italian population 3-6-12 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 basic therapy, by demographic variables (age, sex, geographic origin, basal LDL levels) and by type of prescriber (hospital or territorial).
Description of adherence to treatment with Inclisiran in a real-life Italian population 3-6-12 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.
Description of persistence to treatment with Inclisiran in a real-life Italian population 3-6-12 months Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Federico II University of Naples, Department of Advanced Biomedical Sciences
🇮🇹Napoli, Italy