Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population

Condition(s) studied

Investigational drug(s) / intervention(s)

Tafolecimab: The 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: Cholesterol 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: Statin 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Major adverse cardiovascular and cerebrovascular events (MACCE) — week 104
  The primary endpoint of this trial is major adverse cardiovascular and cerebrovascular events at visit 4 (week 104), defined as the composite endpoints of cardiovascular death, nonfatal MI, nonfatal stroke, hospitalization for unstable angina and coronary revascularization. Coronary revascularization included PCI or coronary artery bypass grafting (CABG). The coronary revascularization will be conducted based on the presence of ischemia. To evaluate the ischemic need for coronary revascularization, specific assessments will be utilized. Laboratory examinations will include blood tests to check for markers of myocardial injury, such as troponins. Electrocardiograms will be assessed. Unstable angina is defined as typical angina symptoms that have worsened in the past month, with a single episode lasting more than half a minute and that do not resolve spontaneously. The definition of MI is referenced from the fourth Universal Definition of Myocardial Infarction (UDMI)

Trial sites (2)

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