The primary objective was to evaluate the effect of PCSK 9 Inhibitor (initiated within 4 h from PCI for the culprit lesion) with high-intensity statin treatment, compared to placebo with high-intensity statin treatment, on cardiovascular events (including cardiovascular death, myocardial infarction, stroke, re-hospitalization due to acute coronary syndromes or heart failure, or any ischemia-driven coronary revascularization) in patients with acute coronary syndrome and multiple lesions. Alirocumab was used before June 10, 2025; Tafolecimab has been used from June 10, 2025 onward.
The subject, or their legal guardian, must have a clear understanding of the trial's design and treatment procedures. They must provide written informed consent before any trial-specific tests or procedures are conducted.
Both male and female subjects aged ≥18 years.
Low-density lipoprotein cholesterol ≥70 mg/dL (≥1.8 mmol/L) in patients who have been on a stable high-intensity statin regimen for at least 4 weeks before enrollment.
Low-density lipoprotein cholesterol ≥90 mg/dL (≥2.3 mmol/L) in patients who have been on a moderate or low-intensity statin regimen before enrollment.
Fasting serum triglyceride levels exceeding 400 mg/dL (exceeding 4.52 mmol/L) before randomization.
Coronary artery disease is located within a saphenous vein graft or an arterial graft.
Residual diameter stenosis greater than 50% as determined by visual examination after percutaneous coronary intervention of the culprit lesion.
TIMI (Thrombolysis in Myocardial Infarction) flow less than 3 in the culprit vessel after PCI.
Parallel
Placebo plus high-intensity statin
DrugAdministered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen, Q2W, and oral administration of rosuvastatin (20 mg, once daily).
PCSK 9 Inhibitor plus high-intensity statin
DrugAdministered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen, Q2W, and oral administration of rosuvastatin (20 mg, once daily).
Cardiovascular events
Cardiovascular events defined as the composite of cardiovascular death, myocardial infarction, stroke or transit ischemic attack, re-hospitalization due to unstable angina or heart failure, or any ischemia-driven coronary revascularization.
Cardiovascular death
It will be adjudicated by an independent external CEC according to protocol defined definition.
All cause death
It is defined as any death from randomization to the last visit.
Myocardial infarction
It will be adjudicated by an independent external CEC.
Stroke
stroke will be adjudicated by an independent external CEC.
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Nanjing First Hospital, Nanjing Medical University
Lead sponsor
National Natural Science Foundation of China
Collaborator
Nanjing Medical University
Collaborator
