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

TRAP-HC is a multicenter, prospective, longitudinal observational study designed to evaluate real-world treatment patterns in adult patients with hypercholesterolemia, including familial hypercholesterolemia (FH), who are at high, very high, or extreme cardiovascular risk. The study aims to generate real-world evidence on lipid control and optimization of lipid-lowering therapies (LLTs) in order to improve cardiovascular risk reduction strategies in high-risk populations.

Cardiovascular disease remains the leading cause of mortality worldwide, and elevated low-density lipoprotein cholesterol (LDL-C) is a major causal determinant of atherosclerotic cardiovascular disease (ASCVD). Current European guidelines recommend a ≥50% reduction in LDL-C levels and the achievement of stringent LDL-C targets in patients at high, very high, and extreme cardiovascular risk. Nevertheless, real-world evidence indicates that a substantial proportion of patients fail to achieve recommended therapeutic goals despite the availability of effective lipid-lowering therapies. European observational studies have shown that approximately 80% of high- and very high-risk patients do not achieve LDL-C targets, with monotherapy still widely used in clinical practice. These findings highlight the need for improved therapeutic strategies and optimization of lipid management in routine care.

The primary objective of the study is to evaluate the evolution of lipid-lowering treatment strategies over a 12-month follow-up period, with particular focus on therapeutic modifications implemented in response to LDL-C levels, the proportion of patients achieving recommended LDL-C targets, and the factors associated with successful target attainment, including baseline cholesterol levels, treatment type, demographic characteristics, comorbidities, and genetic predisposition. The study will also assess patient adherence to prescribed therapies, including treatment persistence, prescription refill patterns, and therapy discontinuation.

Approximately 2,500 adult patients will be enrolled across up to 15 Italian centers affiliated with the LIPIGEN network, all specialized in the management of dyslipidemias. Approximately 85% of the study population is expected to consist of non-FH patients whose cardiovascular risk will be classified according to current clinical guidelines, considering factors such as age, sex, LDL-C levels, blood pressure, smoking status, and other cardiovascular risk markers.

The study is observational and non-interventional in nature; therefore, no treatment assignment or protocol-driven therapeutic modification will be performed by investigators. All patients will continue to receive standard clinical care according to routine medical practice. Patient recruitment is expected to occur over a 6-month enrollment period, followed by a 12-month observational follow-up for each participant. Data routinely collected during clinical practice will be recorded approximately every 6 months when available.