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.
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)
Significant secondary dyslipidemia (e.g. hypertriglyceridemia)
Treatment changes due to non-hypercholesterolemia conditions
Adult patients (≥18 years) with hypercholesterolemia, including those diagnosed with familial hypercholesterolemia (clinical or genetic FH), or patients at high, very high or extreme CVD risk with a baseline visit during a six-month enrollment window.
Cohort
Prospective
Not listed
LDL-C Levels
Distance from LDL-c goal according to EAS/ESC guidelines and the type of lipid lowering approach will be analyzed.
Lipid Profile
This includes total cholesterol, HDL-C, and triglycerides. A measure of cumulative lipid exposure such as "Cholesterol Years" will be determined whenever available. The aim is to evaluate the overall impact of lipid- lowering therapies (LLTs) on the lipid profile and cardiovascular risk reduction.
Adherence to Lipid-Lowering Therapies (LLTs)
Adherence will be assessed according to patients -report and the prescription data collected with Morisky Medication Adherence Scale - 8 items (MMAS-8). Total scores range from 0 to 8, with higher scores indicating better medication adherence. A score of 8 indicates high adherence, scores of 6 to \<8 indicate medium adherence, and scores \<6 indicate low adherence.
Changes in Treatment Regimens
The evolution of LLT regimens will be monitored. Any modifications to the therapies, including dose adjustments or changes in medication, will be recorded and analyzed. Any drug discontinuation and change of treatment will be registered based on patients report.
Patient Attitudes
Surveys conducted as per routine will capture insights into patient attitudes toward hypercholesterolemia treatments.
Clinical Practices
Surveys conducted as per routine will capture insights into new therapeutic evidence.
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Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)
Lead sponsor
CMV-Stat S.r.l.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
