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.
Patients with acute coronary syndrome (ACS) are at high-risk. ACS patients are commonly associated with multiple lesions or multivessel disease. Percutaneous coronary intervention (PCI) is an effective treatment for culprit lesions in ACS. Statin at high-intensity is recommended by current guidelines in order to prevent/slow the progression of non-culprit disease or restenosis. PCSK9 inhibitor serves as the most powerful medication in lowering LDL via promoting the expression of LDL receptors in the liver. However, if the combination of PCSK9 inhibitor with high-intensity statin treatment could significantly reduce the cardiovascular events in patients with ACS who underwent PCI remains unknown. Alirocumab was used before June 10, 2025; Tafolecimab has been used from June 10, 2025 onward.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,212
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen, Q2W, and oral administration of rosuvastatin (20 mg, once daily).
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen, Q2W, and oral administration of rosuvastatin (20 mg, once daily).
Nanjing First Hospital
Nanjing, Jiangsu, China
RECRUITINGCardiovascular 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.
Time frame: 12 months after randomization
Cardiovascular death
It will be adjudicated by an independent external CEC according to protocol defined definition.
Time frame: 12 months after randomization
All cause death
It is defined as any death from randomization to the last visit.
Time frame: 12 months after randomization
Myocardial infarction
It will be adjudicated by an independent external CEC.
Time frame: 12 months after randomization
Stroke
stroke will be adjudicated by an independent external CEC.
Time frame: 12 months after randomization
Ischemia-driven coronary revascularization
It will be adjudicated by an independent external CEC.
Time frame: 12 months after randomization
Re-hospitalization due to unstable angina or heart failure
It will be adjudicated by an independent external CEC.
Time frame: 12 months after randomization
Diagnostic malignant tumor
It will be adjudicated by an independent external CEC.
Time frame: 12 months after randomization
PCSK9 inhibitors or statin intolerance
It will be adjudicated by an independent external CEC.
Time frame: 12 months after randomization
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