Condition: Homozygous Familial Hypercholesterolemia (HoFH) · Coronary Computed Tomography Angiography · Sponsor: Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)
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 L…
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| Unité de Lipidologie et Prévention Cardiovasculaire, Centre de Compétence Dyslipidémies Rares (CEDRA), Service de Nutrition, Hôpital Pitié-Salpétriêre | Paris, France | Not Yet Recruiting |
| Dipartimento Scienze-Cardiovascolari, AO "Sant'Anna e San Sebastiano" di Caserta | Caserta, Italy | Recruiting |
| U.O.C. di Medicina Interna, P.O. Nesima, ARNAS Garibaldi | Catania, Italy | Not Yet Recruiting |
| Nefrologia e Emodialisi, Centro Aterosclerosi e Dislipidemie, Ospedale Bassini, ASST Nord Milano | Cinisello Balsamo, Italy | Recruiting |
| Malattie Aterotrombotiche, Azienda Ospedaliero Universitaria Careggi | Florence, Italy | Recruiting |
| DAI di Medicina Clinica, Centro di Riferimento Regionale di Lipidologia e Dislipidemie, AOU Federico II di Napoli | Naples, Italy | Recruiting |
| UOC Clinica Medica I, AOU di Padova | Padova, Italy | Not Yet Recruiting |
| U.O. Astanteria/MCAU AOU, Policlinico "Paolo Giaccone" di Palermo | Palermo, Italy | Recruiting |
| 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 | Recruiting |
| Medicina Interna, Ospedale Molinette, AOU Città della Salute e della Scienza | Torino, Italy | Not Yet Recruiting |
| Amsterdam University Medical Center, Amsterdam UMC, locatie AMC | Amsterdam, Netherlands | Recruiting |
| Erasmus University Medical Center, Dr. Molewaterplein 40 | Rotterdam, Netherlands | Not Yet Recruiting |
+ 1 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07447648