Primary Hypercholesterolemia in secondary prevention after an acute atherosclerotic, ischaemic cardiovascular event for patients with diagnostically confirmed coronary heart disease and / or peripheral occlusive disease and / or arteria cerebral occlusive disease (excerpt).
Conditions
Interventions
Trade Name: Praluent
Product Name: Alirocumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: alirocumab
CAS Number: 1245916-14-6
Current Sponsor code: unknown
Other descriptive name:
Sponsors
Medical University of Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient scheduled for treatment with Alirocumab in clinical routine (after approval of cost coverage by insurance company) 2. No previous treatment with PCSK9 antibodies 3. Signed informed consent form 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1. Age of < 18 years 2. Pregnancy (pregnancy test at screening visit) 3. Breast-feeding 4. Impossibility to perform magnetic resonance imaging of the carotid artery (claustrophobia, carotid stent)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main target of this prospective pilot-study is to investigate the effects of lipid therapy intensification via the recently approved and very potent monoclonal, human anti-PCSK9 antibody Alirocumab on fractional anisotropy, endothelial function, inflammation, lipoprotein particle subfractions, carotid arteries and post-prandial lipemia in clinical routine at the Medical University of Graz. Main hypothesis: - Fractional anisotropy may be increased in response to Alirocumab.;Secondary Objective: Secondary hypothesis: - Lipid therapy intensification with Alirocumab may improve flow-dependent, endothelium-mediated dilation (Flow-Mediated Dilatation, FMD). - Alirocumab may reduce intima media thickness of the common carotid artery. - Alirocumab may improve the post-prandial lipemia profile. - Alirocumab may induce a change of the lipoprotein subfraction distribution. More precisely, Alirocumab is expected to reduce the number of LDL particles and to increase the number of HDL particles, especially of small ones. - Alirocumab may reduce inflammation ;Primary end point(s): Primary Endpoint: • Change of mean carotid vessel wall fractional anisotropy (2-Dimensional Cardiovascular Magnet Resonance) by very potent lipid-therapy intensification with Alirocumab. ;Timepoint(s) of evaluation of this end point: At week 10 (plus / minus 2 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints: • Change of FDD (flow-dependent dilation) in response to Alirocumab • Change of intima media thickness in response to Alirocumab. • Change of post-prandial lipaemia in response to Alirocumab. • Change of the lipoprotein subfractions in response to Alirocumab • Changes of inflammatory parameters in response to Alirocumab. ;Timepoint(s) of evaluation of this end point: At week 10 (plus / minus 2 weeks). | — |
Countries
Austria
Contacts
Public ContactClinical Department of Angiology
Medical University of Graz
Outcome results
None listed