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
Locations
Sponsors and collaborators
Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)
Lead sponsor
CMV-Stat S.r.l.
Collaborator