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 - ARCHITECT

Fundación Hipercolesterolemia Familiar0 sites162 target enrollmentMarch 14, 2018

Overview

No summary available.

Registry

who.int

Start Date

March 14, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Fundación Hipercolesterolemia Familiar

•\- 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:

•\- 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)