For patients with ACS undergoing PCI, intensive lipid-lowering including PCSK9 monoclonal antibody should be started as soon as possible, that is, lower LDL-C level should be achieved as soon as possible. Compared with conventional lipid-lowering regimen, it is expected that the occurrence of major adverse cardiovascular events can still be reduced after drug discontinuation. Therefore, the optimization strategy of "for patients with ACS undergoing PCI, intensive lipid-lowering with PCSK9 monoclonal antibody can be started as soon as possible" is proposed.
Patients aged 18 to 75 years;
clinical diagnosis with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) ;
undergoing PCI
baseline LDL-C 1.8 mmol/L 3.4 mmol/L note: NSTE-ACS includes non-ST-elevation myocardial infarction and unstable angina.
Severe heart failure (Killip III or IV) or cardiogenic shock;
Previous hemorrhagic cerebrovascular disease history;
Uncontrolled or recurrent arrhythmic events;
poorly controlled hypertension;
Parallel
Tafolecimab
DrugThe PCSK9 mAb in this study is defined as Tafolecimab 150mg q2w subcutaneously. For the two groups of lipid-lowering regimens, the lipid-lowering drug regimens other than PCSK9 mAb were maintained throughout the study as much as possible in accordance with the guidelines related to blood lipids, provided that no serious safety problems occurred.
Cholesterol Absorption Inhibitor
DrugCholesterol absorption inhibitors (like Ezetimibe and Hybutimibe) are based on physician decisions, but need to be routinely dosed. Examples of Medications that Meet Study Requirements: Ezetimibe 10mg Po qd.
Statin
DrugStatin are based on physician decisions, but need to be routinely dosed. Examples of Medications that Meet Study Requirements: Atorvastatin 20mg Po qn, Rosuvastatin 10mg Po qn or Pitavastatin 4mg Po qn.
Major adverse cardiovascular and cerebrovascular events (MACCE)
Including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina, and coronary revascularization). The coronary revascularization includes coronary intervention (PCI), coronary artery bypass grafting (CABG).
major adverse cardiovascular events (MACEs)
Cardiovascular death, nonfatal myocardial infarction, hospitalization for unstable angina, and coronary revascularization.
Major adverse cardiovascular and cerebrovascular events (MACCE)
Including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina, and coronary revascularization). The coronary revascularization includes coronary intervention (PCI), coronary artery bypass grafting (CABG).
Additional observed endpoint 1
Cardiovascular death
Additional observed endpoint 2
non-fatal myocardial infarction
Additional observed endpoint 3
non-fatal stroke
Additional observed endpoint 4
hospitalization for unstable angina
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China National Center for Cardiovascular Diseases
Lead sponsor
Innovent Biologics, Inc.
Collaborator
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