Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardi… (NCT06372925) | Clinical Trial Compass
RecruitingPhase 4
Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction
China334 participantsStarted 2024-07-09
Plain-language summary
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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female ≥ 18 and ≤ 75 years of age.
✓. Acute myocardial infarction (STEMI ≤ 24h/NSTEMI ≤ 72h of onset of symptoms) with planned PCI.
✓. At least 1 major, non-infarct-related coronary artery ("target vessel") meet all of the following criteria judged by the investigator:
✓. 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.
Exclusion criteria
✕. 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.
✕. Have a plan for interventional procedure within 12 months after signing ICF.
✕. Known intolerance to Atorvastatin OR known statin intolerance.
✕. Patients already on high-intensity statin including atorvastatin 40 or 80 mg or rosuvastatin 20 mg upon signing ICF.