Not Yet RecruitingNot Applicable

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

2,500 participantsStarted 2026-06-30

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * Significant secondary dyslipidemia (e.g. hypertriglyceridemia) * Treatment changes due to non-hypercholesterolemia conditions

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

LDL-C Levels

Timeframe: Baseline, 6 months and 12 months

Lipid Profile

Timeframe: Baseline, 6 months and 12 months

Trial details

NCT IDNCT07606118

SponsorFondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Hypercholesterolaemia trials