Evinacumab and Coronary Artery Plaque in Homozygous Familial Hypercholesterolemia
Looks at evinacumab's effect on artery plaque in people with homozygous familial hypercholesterolemia.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Amsterdam and Rotterdam, NetherlandsSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with homozygous familial hypercholesterolemia (HoFH) whose LDL cholesterol stays high despite treatment. One group takes Evinacumab; the other group does not.
- Age
- 12 years or older (18 years or older in Italy and France).
- Sex
- All sexes can join.
- Disease stage
- Clinical or genetic diagnosis of HoFH, with LDL-cholesterol of 140 mg/dl (3.5 mmol/L) or higher despite lipid-lowering treatment.
- Earlier treatment
- Evinacumab group: started Evinacumab within 24 months before joining, on top of lipid-lowering treatment at a stable dose for at least 30 days before. Other group: standard lipid-lowering treatment (statin, ezetimibe, PCSK9-directed therapy) at a stable dose for at least 30 days before a baseline CCTA, and no Evinacumab.
- Biomarker or test result
- Baseline CCTA and a follow-up CCTA 18-24 months later must be available. Evinacumab group: baseline CCTA at least 6 months before or 1 month after Evinacumab start.
Main reasons for not taking part
- Took part in a trial with an investigational drug within the last 6 months
- Previous multi-vessel coronary artery bypass surgery (CABG)
- Moderate to severe kidney problems, or end-stage kidney disease with kidney transplant or long-term dialysis
- Pregnant at the time of the lipid-lowering treatment
- Cannot get enough past medical records, or cannot or will not give consent
Read by machine on 9 November 2026.
Where in Netherlands
- Amsterdam University Medical Center, Amsterdam UMC, locatie AMCAmsterdam, NetherlandsTaking people
- Erasmus University Medical Center, Dr. Molewaterplein 40Rotterdam, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)
- Trial code
- NCT07447648
- Record updated
- 21 August 2026
- Original description
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).Read full original descriptionShow less
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): A Real World, Prospective and Retrospective, Observational Study
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.
Inclusion: Willing and able to provide written informed consent form/assent form for the use of retrospective and prospective data; Male or female patients aged ≥12 years old at time of enrolment (exception for Italy and France ≥18 years); Clinical or genetic diagnosis of Homozygous Familial Hypercholesterolemia (HoFH) according to the consensus statement by Cuchel et al, 2023; EHJ (14); Patients who initiated Evinacumab (at the approved dosage and administration) within 24 months before enrolment as add-on to lipid-lowering treatment (with statins, ezetimibe, PCSK9i and/or other agents or treatment) at stable dose for at least 30 days before Evinacumab initiation, as per routine clinical care and no change in dosing is anticipated; Availability of a baseline CCTA performed at least 6 months prior or 1 month after Evinacumab initiation and a follow-up CCTA performed 18-24 months after Evinacumab initiation; LDL-cholesterol ≥ 140 mg/dl (3.5 mmol/L) despite lipid-lowering treatment; Willing and able to provide written informed consent form/assent form for the use of retrospective and prospective data; Male or female patients aged ≥12 years old at time of enrolment (exception for Italy and France ≥18 years); Clinical or genetic diagnosis of Homozygous Familial Hypercholesterolemia (HoFH) according to the consensus statement by Cuchel et al, 2023; EHJ (14); Patients with HoFH on standard lipid-lowering therapy (statins, ezetimibe, PCSK9i and/or other agents or treatment) at stable dose for at least 30 days before a baseline CCTA and with a follow-up CCTA after 18-24 months from the baseline one; Required lipid lowering therapies: statin, ezetimibe and PCSK9 directed therapy (unless discontinuation due to <15% LDL-cholesterol reduction); Optional additional lipid-lowering therapies:; Lipoprotein apheresis, at stable intervals for at least 3 months; Lomitapide, at stable dose for at least 3 months; LDL-cholesterol ≥ 140 mg/dl (3.5 mmol/L) despite lipid-lowering treatment.
Exclusion: Patients participating in a clinical trial with an investigational drug within the last 6 months; Previous multi-vessel coronary artery bypass grafting (CABG). Patients with single-vessel CABG are not excluded; Participation in any interventional clinical trial involving investigational drugs within the last 6 months; Previous multi-vessel coronary artery bypass grafting (CABG). Patients with single-vessel CABG are not excluded; Moderate to severe renal impairment, or end-stage renal disease (ESRD) undergoing kidney transplantation or chronic renal replacement therapy; Moderate to severe renal impairment, or end-stage renal disease (ESRD) undergoing kidney transplantation or chronic renal replacement therapy; Patients treated outside of Evinacumab approved indication; Inability to access adequate retrospective clinical data from medical records; Inability or unwillingness to provide informed consent/assent or refusal to participate; Pregnancy at the time of the LLT administration; Inability to access adequate retrospective clinical data from medical records; Inability or unwillingness to provide informed consent/assent or refusal to participate; Pregnancy at the time of the LLT administration.