This study is to evaluate the effect of Inclisiran on coronary atherosclerosis using intravascular ultrasound (IVUS) and optical coherence tomography (OCT) in patients with acute myocardial infarction and elevated low-density lipoprotein cholesterol (LDL-C).
Male or female ≥ 18 and ≤ 75 years of age.
Acute myocardial infarction (STEMI ≤ 24h/NSTEMI ≤ 72h of onset of symptoms) with planned PCI.
LDL-C > 1.8 mmol/L if on stable dose of statin (with or without ezetimibe) for ≥ 4 weeks upon signing ICF.
LDL-C > 2.6 mmol/L if not on stable dose of statin (with or without ezetimibe) for ≥ 4 weeks upon signing ICF.
Familial hypercholesterolemia or secondary hypercholesterolemia.
Clinically instable AMI (hemodynamic or electrical instability).
Left main disease, defined as ≥ 50% diameter stenosis of the left main coronary artery by coronary angiography.
Three-vessel disease, defined as ≥ 70% diameter stenosis of 3 major epicardial coronary vessels or in major branches of these arteries by coronary angiography.
Parallel
atorvastatin
Drug20mg atorvastatin PO
IVUS/OCT
Procedure/Surgeryperformed the IVUS/OCT at baseline and Day 360
inclisiran
DrugInclisiran 284mg SC
Change in percent atheroma volume (PAV)
Change in PAV assessed by intravascular ultrasound (IVUS) from baseline to Day 360.
Change in minimum fibrous cap thickness (FCT)
Change in minimum FCT as determined by optical coherence tomography (OCT) from baseline to Day 360
Change in mean minimum FCT of all images
Change in mean minimum fibrous cap thickness (FCT) of all images as determined by OCT from baseline to Day 360.
Change in normalized total atheroma volume (NTAV)
Change in NTAV as determined by intravascular ultrasound (IVUS) from baseline to Day 360
Proportion of participants with progression, regression, or no change in PAV
Proportion of participants with progression, regression, or no change in percent atheroma volume (PAV) at Day 360
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