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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFederico II University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients under Inclisiran treatment

Disqualifiers

Age < 18 years o > 80 years

Patients who refuse to participate and to sign informed consent

Trial population

The study population includes patients from Italy, who have received Inclisiran as part of routine clinical management of their hyperlipidaemia, based on national reimbursement criteria, at time of enrollment

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

  • Inclisiran

    Drug

    Injection

Treatment groups

3,000 Participants
are divided into 1 treatment group
Group A: Subjects with hyperlipidaemia under Inclisiran treatment1 intervention

Trial outcomes

Primary outcomes

1

Description of adherence to treatment with Inclisiran in a real-life Italian population

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.

Time frame
at 3 months and every 6 months thereafter
2

Description of persistence to treatment with Inclisiran in a real-life Italian population

Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment.

Time frame
at 3 months and every 6 months thereafter
3

Description of efficacy of treatment with Inclisiran in a real-life Italian population

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).

Time frame
at 3 months and every 6 months thereafter

Secondary outcomes

Other outcomes

Sponsors and contacts

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