Early Intensive Lipid-Lowering With Inclisiran for Plaque Stabilization in Acute Coronary Syndrome

Inclusion criteria

• Age 19 to 85 years.
• Hospitalization for acute coronary syndrome (UA, NSTEMI, or STEMI) with planned coronary angiography and PCI, or PCI already performed during the index hospitalization with adequate baseline OCT images obtained during the procedure that meets the study imaging analysis criteria.
• Presence of a target vessel/segment considered by the investigator to be suitable for OCT assessment at baseline and at the 12-month follow-up.
• LDL-C level at screening meeting one of the following criteria according to background lipid-lowering therapy:

i) ≥40 mg/dL in patients receiving stable combination therapy with a statin and ezetimibe, defined as no dose change for at least 4 weeks before screening; ii) ≥55 mg/dL in patients receiving high-intensity statin therapy; iii) ≥70 mg/dL in patients receiving low- or moderate-intensity statin therapy; or iv) ≥100 mg/dL in patients not receiving stable statin therapy.

• Provision of voluntary written informed consent after receiving sufficient information regarding the study objectives, procedures, and follow-up plan.

Exclusion criteria

• Severe hepatic dysfunction, defined as AST or ALT >3 times the upper limit of normal.
• CK >5 times the upper limit of normal or suspected clinically significant myopathy.
• Severe renal impairment, defined as eGFR <30 mL/min/1.73 m².
• Severe hypersensitivity to or contraindication to statins, ezetimibe, or inclisiran.
• Pregnancy, breastfeeding, or plans to become pregnant during the study period.
• Inability to undergo 12-month follow-up coronary angiography and OCT.
• Life expectancy <1 year or, in the investigator's judgment, inappropriate participation in the study because of concerns regarding adherence or safety.