Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNovartis Pharmaceuticals

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • atorvastatin
  • IVUS/OCT
  • inclisiran

Treatment groups

318 Participants
are divided into 2 treatment groups

Sponsors and collaborators