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Investigating the Effects of Lipid-therapy Intensification With Alirocumab on Endothelial Function, Carotid Arteries, Lipoprotein Particle Subfractions, Inflammation and Post-prandial Lipemia

NCT03559309

TerminatedPhase 4

Sponsor: Medical University of Graz

Conditions: Atherosclerosis, Hypercholesterolemia, Post Prandial Lipemia, Cardiovascular Diseases

Interventions: Magnet Resonance Tomography, Carotid Arteries Sonography, Flow-mediated Dilation, Fat-tolerance Test, Laboratory Testing

Countries: Austria

A prospective, open-label, pilot study with 24 cardiovascular high risk patients (N=24) having insufficient Low density lipoprotein cholesterin (LDL-C) reduction despite standard of care lipid-modifying therapies (LMTs), to evaluate the effects of potent lipid-therapy intensification via the recently approved monoclonal, human anti-PCSK9 antibody Alirocumab on endothelial function, inflammation, lipoprotein particle subfractions, carotid arteries and post-prandial lipemia in clinical routine at the Medical University of Graz.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

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)

Locations (1)

Graz, Styria, Austria