Assessing the Impact of Intensification of Lipid Lowering Therapy With Guidelines-based Evinacumab Administration on Coronary Plaque Volumes Measured by Coronary Computed Tomography Angiography (CCTA) in Patients With Homozygous Familial Hypercholesterolemia (HoFH)
Recruiting now
Conditions studied: Homozygous Familial Hypercholesterolemia (HoFH), Coronary Computed Tomography Angiography
In brief
This observational, multicenter, retrospective and prospective study aims to evaluate the impact of intensified lipid-lowering therapy including Evinacumab on coronary atherosclerotic plaque burden in patients with Homozygous Familial Hypercholesterolemia (HoFH). HoFH is a rare genetic disorder characterized by extremely elevated low-density lipoprotein cholesterol (LDL-C) levels from early life and a markedly increased risk of premature atherosclerotic cardiovascular disease. Despite combination lipid-lowering therapy, many patients do not achieve recommended LDL-C targets and remain at high cardiovascular risk. Evinacumab, a monoclonal antibody targeting angiopoietin-like protein 3 (ANGPTL3), has demonstrated significant LDL-C reduction in clinical trials. However, real-world evidence on its impact on coronary plaque progression is limited. The study will compare HoFH patients receiving intensified lipid-lowering therapy including Evinacumab with patients receiving conventional lipid-lowering therapy without Evinacumab. Coronary plaque burden and phenotype will be assessed using coronary computed tomography angiography (CCTA) performed as part of routine clinical practice. Approximately 52 patients will be enrolled across European centers. The primary objective is to evaluate changes in non-calcified coronary plaque volume between baseline and 18-24 months' follow-up. Secondary objectives include evaluation of total plaque burden, high-risk plaque characteristics, and LDL-C reduction. Exploratory analyses will assess patient-reported outcomes, pericoronary adipose tissue characteristics, and supravalvular atherosclerosis. All data are collected from routine clinical care. No additional procedures are mandated by the protocol. This study aims to generate real-world imaging evidence on the effect of intensified lipid-lowering therapy including Evinacumab on coronary atherosclerosis in HoFH.
Key facts
- Study ID
- NCT07447648
- Run by
- Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)
- People needed
- 52
- Starts
- 2026-04-30
- Expected to finish
- 2029-02-01
- Last updated by the study team
- 2026-05-14
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Centro per le Malattie Rare del Metabolismo dei Lipidi, Unità di Medicina Interna e Malattie Metaboliche, Dipartimento di Medicina Traslazionale e di Precisione Sapienza, Università di Roma — Roma, Italy (enrolling)
- Nefrologia e Emodialisi, Centro Aterosclerosi e Dislipidemie, Ospedale Bassini, ASST Nord Milano — Cinisello Balsamo, Italy (enrolling)
- Amsterdam University Medical Center, Amsterdam UMC, locatie AMC — Amsterdam, Netherlands (enrolling)
- Malattie Aterotrombotiche, Azienda Ospedaliero Universitaria Careggi — Florence, Italy (enrolling)
- Ege University,Director of Lipid and Prevention Clinic, Department of Cardiology — Bornova, Turkey (Türkiye) (enrolling)
- DAI di Medicina Clinica, Centro di Riferimento Regionale di Lipidologia e Dislipidemie, AOU Federico II di Napoli — Naples, Italy (enrolling)
- Dipartimento Scienze-Cardiovascolari, AO "Sant'Anna e San Sebastiano" di Caserta — Caserta, Italy (enrolling)
- U.O. Astanteria/MCAU AOU, Policlinico "Paolo Giaccone" di Palermo — Palermo, Italy (enrolling)
- UOC Clinica Medica I, AOU di Padova — Padova, Italy
- U.O.C. di Medicina Interna, P.O. Nesima, ARNAS Garibaldi — Catania, Italy
- Unité de Lipidologie et Prévention Cardiovasculaire, Centre de Compétence Dyslipidémies Rares (CEDRA), Service de Nutrition, Hôpital Pitié-Salpétriêre — Paris, France
- Medicina Interna, Ospedale Molinette, AOU Città della Salute e della Scienza — Torino, Italy
- Erasmus University Medical Center, Dr. Molewaterplein 40 — Rotterdam, Netherlands
Full record on ClinicalTrials.gov
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