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: Protocol of the TRAP-HC Study
TRAP-HC Study
Copyright (c) 2026 Chiara Crosti, Aurora Marchesin, Manuela Casula, Elena Olmastroni, Alberico L. Catapano
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
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Published: April 30, 2026
Abstract
Background: Elevated low-density lipoprotein cholesterol (LDL-C) is a causal driver of atherosclerotic cardiovascular disease (ASCVD). Although current European guidelines recommend intensive LDL-C lowering strategies in high, very high, and extreme cardiovascular risk patients, real-world data consistently show suboptimal goal achievement.
Aim and Methods: The TRAP-HC study aims to evaluate real-world treatment patterns, LDL-C goal attainment, and adherence to lipid-lowering therapies (LLTs) in patients with hypercholesterolemia, including familial hypercholesterolemia (FH), at high, very high, and extreme cardiovascular risk over a 1-year follow-up.
TRAP-HC is a multicenter, prospective, longitudinal, observational study conducted across up to 15 lipid clinics within the Italian LIPIGEN network. Approximately 2,500 adult patients will be enrolled and followed for one year. The primary endpoint will be the change in LDL-C levels and achievement of guideline-recommended LDL-C goals. Secondary endpoints will include adherence, treatment intensification patterns, and patient-reported attitudes toward therapy.
Conclusion: TRAP-HC will provide contemporary real-world evidence on lipid management in high-risk populations and identify gaps between guideline recommendations and clinical practice.
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