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NCT07606118Not yet recruiting

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

An Observational Longitudinal Multicenter Prospective Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia, Over a 1-Year Follow- Up

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
2500 (estimated)
First submitted
12 May 2026
Start date
1 Jan 2027
Primary completion date
1 Jun 2028
Lead sponsor
Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)
NCT number
NCT07606118

What you commit to

  • Study type: Observational
  • Planned participants: 2500
  • From 1 Jan 2027 to the primary completion date, 1 Jun 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Treatment changes due to non-hypercholesterolemia conditions

Other

  • Significant secondary dyslipidemia (e.g. hypertriglyceridemia)

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.