Ignite Creation Date:
2024-05-06 @ 9:46 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03067844
Status:
COMPLETED
Last Update Posted:
2022-02-24
First Post:
2017-02-24
Brief Title:
Vascular Effects of Alirocumab in Acute MI-Patients
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
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
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACMAN-AMI
Brief 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 11 ratio to either alirocumab or placebo
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 11 ratio to either alirocumab or placebo
Detailed Description:
Substudies
Biobankdrug monitoring all sites
Lipidomics n294 all sites
Platelet Function n150 Bern
Endothelial Function n150 Bern
Neatherosclerosis n294 all sites
Neutrophilic Extracellular Trap NET n50 Vienna
OCT-NIRSIVUS Matching Substudy n104 Bern
Positron Emission Computed Tomography PET-CT n50 Copenhagen
Shear Stress n294 London
Quantitative Flow Ratio QFR n294 Bern
Biobankdrug monitoring all sites
Lipidomics n294 all sites
Platelet Function n150 Bern
Endothelial Function n150 Bern
Neatherosclerosis n294 all sites
Neutrophilic Extracellular Trap NET n50 Vienna
OCT-NIRSIVUS Matching Substudy n104 Bern
Positron Emission Computed Tomography PET-CT n50 Copenhagen
Shear Stress n294 London
Quantitative Flow Ratio QFR n294 Bern
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None