ow interventional, open and multicentric clinical trial to evaluate the effect of alirocumab on volume, architecture and composition of atheroma plaque in patients with familial hypercholesterolemia from SAFEHEART registry. ARCHITECT study

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 162

Inclusion Criteria

- Signed informed consent before the beginning of specific trial procedures
- ;ail or female patients, aged between 35 and 65 years
- Patients with molecular diagnostic of Familial Hypercholesterolemia, enrolled on spanish registry SAFEHEART
- Asymptomatc patients
- Patients without previous history of clinical cardiovascular events (myocardial acute infarction, stroke, coronary revascularization...)
- Patiens receiving optimized and stable treatment with maximum tolerated doses of statins in combination or not with other lipid-lowering drugs during at least three months, with inappropiate control, defined by cLDL>100mg/dl
- Patiens with PAV > 30% on basal coronary ACT, carried out on the last three months before basal visit
- Patients with indication of alirocumab 150 mg/ml treatment, according to patient's characteristics and technical data sheet
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 162
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Class >II cardiac insufficiency according to NYHA scale (New York Heart Association)
- Cardiac Rhythm different to normal sinus rhythm (regular CF betwen 60-100 beat per min)
- Previous history of myocardial acute infarction, peripheral arterial thrombosis, stroke or transient ischemic attack
- Uncontrolled Hypertension, defined as systolic pressure value at rest >180mmHg at basal visit
- Fast triglycerides >250 mg/dl at baseline
- Type 1 or type 2 diabetes poorly controlled (HB1A>9%)
- History of hereditary muscular disorders
- Thyroid disease or thyroid hormone replacement therapy
- Glomerular filtration rate < 60 ml/min/1,73m2 at baseline
- High levels of AST and/or ALT (>3 ULN levels at baseline)
- High levels of creatinine kinase (>3 ULN at baseline)
- Patients that have been treated previously with IPCSK9, CETP inhibitors, mipomersen and/or lomitapide
- Statin-intolerant patients
- Active cancer disease or previous history of cancer
- Active clinically relevant infections or significative hematologycal, metabolic, gastrointestinal, endocrine or kidney dysfunction
- Availability of coronary angioCT at baseline that does not fulfill technical requisites for being processed with QAngio CT software
- Patients enrolled in clinical trials, except in case that study treatment has been discontinued more than 6 months before the beginning of the study
- Pregnant or lactating women, or fertile women that are not willing to use an appropiate anticonceptive method