Alirocumab and Plaque Burden In Familial Hypercholesterolaemia (NCT05465278) | Clinical Trial Compass
CompletedPhase 4
Alirocumab and Plaque Burden In Familial Hypercholesterolaemia
Spain104 participantsStarted 2018-05-01
Plain-language summary
Low-level, open-label, multicenter clinical trial to evaluate the effect of alirocumab on the volume, architecture and composition of atherosclerotic plaque in patients with Familial hypercholesterolemia from the SAFEHEART Registry. ARCHITECT study
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Have voluntarily granted informed consent (preferably in writing or, failing that, orally before independent witnesses of the research team) before carrying out the specific procedures of the trial.
* Patients of both sexes aged between 35 and 65 years.
* Patients with a molecular diagnosis of heterozygous HF included in the Spanish SAFEHEART registry (http://safeheart.colesterolfamiliar.org/).
* Asymptomatic patients.
* Patients without a previous history of clinical cardiovascular events (acute myocardial infarction \[AMI\], stroke, coronary revascularization, etc.).
* Patients on optimized and stable treatment with maximum tolerated doses of a statin with or without other lipid-lowering therapies, for at least 3 months, with inadequate control, defined by a LDL-C level\> 100 mg / dL.
* Availability of a coronary CTA performed in the 3 months prior to the baseline visit. If a coronary CTA is not available, this test will be performed during the selection period.
* ATC of at least 64 cuts performed in a center with sufficient experience (more than 100 ACTs per year).
* Patients with a PVA\> 30% in the baseline coronary CTA, performed in the last 3 months before the baseline visit.
* Patients in whom treatment with alirocumab 150 mg / mL is indicated, according to the characteristics of the patient and the Praluent® technical data sheet.
Exclusion Criteria:
* Class\> II heart failure according to the functional classification of the NYHA scale (New Yo…
What they're measuring
1
Change in atherosclerotic plaque burden (%) assessed by coronary computed tomography