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

NCT03559309 | Terminated Phase 4

• 1 other identifier: ALIROCKS_05MAR2018_V3
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atherosclerosis; Hypercholesterolemia; Post Prandial Lipemia; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Change of mean carotid vessel wall fractional anisotropy (2-Dimensional Cardiovascular Magnet Resonance) by very potent lipid-therapy intensification with Alirocumab

  Study participants will undergo a cardiovascular magnetic resonance imaging of the carotid vessels. High resolution diffusion tensor imaging (DTI) will be performed on one selected axial slice using read-out segmented EPI (rs-EPI) sequence on a 3T MR scanner.

  From baseline to 10 weeks of treatment

Secondary Outcomes (5)

• Change of FDD (flow-dependent dilation) in response to Alirocumab

  From baseline to 10 weeks of treatment

• Change of intima media thickness in response to Alirocumab

  From baseline to 10 weeks of treatment

• Change of post-prandial lipaemia in response to Alirocumab

  From baseline to 10 weeks of treatment

• Change of the lipoprotein subfractions in response to Alirocumab

  From baseline to 10 weeks of treatment

• Changes of inflammatory parameters in response to Alirocumab

  From baseline to 10 weeks of treatment

Study Arms (1)

Alirocumab

OTHER

Medical Treatment (Clinical Routine)

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

Interventions

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

Patients treated with Alirocumab in the clinical routine will have additional diagnostic tests as stated above. The clinical trial will be conducted as an open label, single arm study. The diagnostic tests will be done at baseline (BL) and after 10 weeks of treatment (W10) with Alirocumab.

Alirocumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient scheduled for treatment with Alirocumab in clinical routine (after approval of cost coverage by insurance company)
• No previous treatment with PCSK9 antibodies
• Signed informed consent form

You may not qualify if:

• Age of \< 18 years
• Pregnancy (pregnancy test at screening visit)
• Breast-feeding
• Impossibility to perform magnetic resonance imaging of the carotid artery (claustrophobia, carotid stent)

Sponsors & Collaborators

• Medical University of Graz: lead
• numares AG: collaborator
• Sanofi: collaborator

Study Sites (1)

Medical University of Graz

Graz, Styria, A-8036, Austria

Location

MeSH Terms

Conditions

Atherosclerosis; Hypercholesterolemia; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Günther Silbernagel, MD. Ass.Prof.

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 18, 2018
• Study Start: June 20, 2018
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)