An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)

About this trial

TRAP-HC is a multicenter, observational, longitudinal, prospective study designed to evaluate real-world treatment patterns and lipid-lowering therapy (LLT) management in patients with hypercholesterolemia, including familial hypercholesterolemia (FH), who are at high, very high, or extreme cardiovascular risk. Approximately 2,500 adult patients will be enrolled across up to 15 Italian LIPIGEN network centers and followed for 12 months as part of routine clinical practice.

The study aims to assess LDL-C goal attainment according to current European guidelines, evaluate changes in lipid profiles over time, and investigate treatment adherence, persistence, and therapeutic modifications in response to clinical needs. Data collected during routine visits will include lipid parameters, cardiovascular history, concomitant therapies, safety outcomes, and patient-reported adherence measures.

By providing real-world evidence on the management of hypercholesterolemia in high-risk populations, the study seeks to identify current gaps between guideline recommendations and clinical practice and to support optimization of cardiovascular risk reduction strategies.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Diagnosis of hypercholesterolemia (including clinical or genetic FH) OR high/very high/extreme CV risk

Baseline visit within enrollment window (six months)

Disqualifiers

Significant secondary dyslipidemia (e.g. hypertriglyceridemia)

Treatment changes due to non-hypercholesterolemia conditions

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

2,500 Participants
are grouped into 1 trial group

Locations

This trial has no locations

Sponsors and collaborators