Alirocumab and Plaque Burden In Familial Hypercholesterolaemia

• Status: Completed
• Trial end date: 2022-03-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Hipercolesterolemia Familiar

Criteria

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 York Heart Association).

• Heart rate different from normal sinus rhythm (regular HR between 60-100 bpm).

• Previous history of AMI, angina, peripheral arterial thrombosis, stroke or transient ischemic attack (TIA).

• Uncontrolled hypertension defined as a resting systolic blood pressure value> 180 mmHg at the baseline visit.

• Fasting triglyceride levels> 250 mg / dl at baseline visit.

• Type 1 diabetes or insufficiently controlled type 2 diabetes (HbA1> 9%).

• Personal or family history of inherited muscle disorders.

• Known thyroid disease or thyroid replacement therapy.

• Glomerular filtration rate <60 ml / min / 1.73 m2 at baseline visit.

• Elevated ALT and / or AST levels (> 3 times the ULN at the baseline visit).

• Elevated creatinine kinase levels (> 3 times ULN at baseline).

• Patients who have previously received iPCSK9, CETP (cholesterol ester transport protein) inhibitors, mipomersen and / or lomitapide.

• Patients with statin intolerance.

• Active cancer or previous history of cancer.

• Clinically relevant active infection or clinically significant hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction.

• Availability of a baseline coronary ACT that does not meet the technical requirements for the images to be adequately processed using the QAngio CT software.

• Patient being treated with any investigational drug / product or participating in a clinical trial using an investigational product, with the exception of studies in which the study treatment has been completed more than 6 months ago.

• Pregnant or breast-feeding women, and sexually active women of childbearing potential who are unwilling to use an adequate contraceptive method (such as oral contraceptives, intrauterine device, or barrier method of contraception along with spermicide or surgical sterilization) during the study. Women of childbearing age are defined as those women who have not undergone permanent infertility procedures or who have been amenorrheic for less than 12 months.