Alirocumab and Plaque Burden In Familial Hypercholesterolaemia

Sponsor
Fundación Hipercolesterolemia Familiar
Study ID
NCT05465278
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alirocumab — DRUG
    18 months treatment with alirocumab

Study Details

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

Key Dates

Start date
May 1, 2018
Status verified
Jul 2022
Primary completion
Mar 30, 2022
Completion
Mar 30, 2022

Study Design

Enrollment
104 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Alirocumab
    Every patient enrolled witll receive treatment witl Alirocumab

Primary Outcome Measure

Change in atherosclerotic plaque burden (%) assessed by coronary computed tomography [ Time Frame: 18 months ]

Related Studies