NCT03067844

Vascular Effects of Alirocumab in Acute MI-Patients

Effects of the PCSK9 Antibody AliroCuMab on Coronary Atherosclerosis in PatieNts With Acute Myocardial Infarction: A Serial, Multivessel, Intravascular Ultrasound, Near-Infrared Spectroscopy And Optical Coherence Tomography Imaging Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 294 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Coronary artery disease (CAD) is the most frequent cause of mortality in the industrialized world. Hypercholesterolemia is a major risk factor for the development and progression of CAD. While statins currently represent the first-line, gold-standard therapy for primary and secondary prevention of cardiovascular morbidity and mortality, nearly 50% of patients in Europe and Canada treated with statins do not achieve their target levels of low-density lipoprotein cholesterol (LDL-C) or cannot tolerate effective statin doses. Recently, a growing number of studies of PCSK9 inhibitors in a wide spectrum of patients with hyperlipidemia on or off lipid-lowering therapy, familial hypercholesterolemia, and statin intolerance demonstrated consistent, profound, and sustained reductions in LDL-C with greater magnitude of reduction as compared with high-dose statin regimens. However, the effects of PCSK9 inhibition on coronary plaque morphology remain unknown. This study will investigate the effect of the PCSK9 inhibitor alirocumab in patients with acute myocardial infarction undergoing percutaneous coronary intervention (PCI) in the infarct-related artery and receiving guideline-recommended high-intensity statin therapy. A serial, multivessel, intravascular ultrasound, near-infrared spectroscopy and optical coherence tomography imaging study will be performed to determine the change in plaque volume at week 52. A total of 294 patients will be enrolled in the study and randomized in a 1:1 ratio to either alirocumab or placebo.

Detailed description

Substudies * Biobank/drug monitoring, all sites * Lipidomics (n=294), all sites * Platelet Function (n=\~150), Bern * Endothelial Function (n=\~150), Bern * Neatherosclerosis (n=\~294), all sites * Neutrophilic Extracellular Trap (NET), (n=\~50), Vienna * OCT-NIRS/IVUS Matching Substudy (n=\~104), Bern * Positron Emission Computed Tomography (PET-CT), (n=\~50), Copenhagen * Shear Stress (n=\~294), London * Quantitative Flow Ratio (QFR) (n=\~294), Bern

Conditions

• Coronary Vessel
• Coronary Circulation
• Atheroma; Myocardial

Interventions

Type	Name	Description
DRUG	Alirocumab	Pre-filled auto-injector pen every second week, starting at day 1 and up to week 50

Timeline

• Start date: 2017-04-25
• Primary completion: 2021-10-13
• Completion: 2021-10-13
• First posted: 2017-03-01
• Last updated: 2022-02-24

Locations

9 sites across 4 countries: Austria, Denmark, Netherlands, Switzerland