1. Main objective Among patients with elevated Lp(a) levels (\>30mg/dL) who did not experience cardiovascular events or BARC type 2, 3, or 5 bleeding within 12 months after PCI and DES implantation, was it possible to reduce the primary adverse cardiovascular and cerebrovascular events (a composite endpoint consisting of all-cause death, non-fatal myocardial infarction, and stroke) by extending the duration of DAPT (24 months) compared to the standard duration (12 months)? (Efficacy test) 2. Secondary Objectives Key secondary research objective: Among patients with elevated Lp(a) levels (\> 30mg/dL) who underwent PCI and received DES implantation within 12 months after the procedure, and who did not experience cardiovascular events or BARC type 2, 3, or 5 bleeding, whether extending the DAPT duration (24 months) compared to the standard DAPT duration (12 months) does not result in an increase in clinical net adverse events (a composite endpoint consisting of all-cause death, non-fatal myocardial infarction, stroke, and BARC type 3 or 5 bleeding) compared to the standard DAPT duration. (Non-inferiority test) Other secondary research objectives: To evaluate the differences in the incidence of the composite endpoint consisting of BARC type 3 or 5 bleeding (the primary safety endpoint) between extending the DAPT duration (24 months) and the standard DAPT duration (12 months); the differences in the incidence of the composite endpoint consisting of cardiovascular death and myocardial infarction; the differences in the incidence of the composite endpoint consisting of all-cause death and myocardial infarction; the differences in the incidence of stent thrombosis; the differences in the incidence of any myocardial infarction; the differences in the incidence of target vessel myocardial infarction; the differences in the incidence of stroke; the differences in the incidence of ischemic stroke; the differences in the incidence of hemorrhagic stroke; the differences in the incidence of cardiovascular death; the differences in the incidence of all-cause death; the differences in the incidence of repeat revascularization; the differences in the incidence of target vessel revascularization; the differences in the incidence of BARC type 2, 3, or 5 bleeding; the differences in the incidence of any bleeding.
Male or nonpregnant female between 18-75 years;
Subjects with Lp(a) levels > 30mg/dL before percutaneous coronary intervention (PCI);
PCI procedure with drug-eluting stent (DES) implantation and no cardiovascular events or BARC type 2, 3, or 5 bleeding events occurring within 12 months after the procedure
Subjects (or legal guardian) understand the trial requirements and the treatment procedures and provides written informed;
Subjects with Lp(a) < 30mg/dL or Lp(a) level unavailable before PCI;
Subjects who experience adverse cardiovascular events (death, myocardial infarction, stent thrombosis, stroke, repeat coronary revascularization, or Bleeding Academic Research Consortium [BARC] type 2, 3 or 5 bleeding) within 1-year after PCI;
BARC type 2, 3, or 5 bleeding occurred before PCI
Unable to tolerate DAPT therapy or anticoagulant therapy at the same time, long-term use of non-steroidal anti-inflammatory drugs is required Or glucocorticoids;
Parallel
24 Months DAPT
Procedure/SurgeryAll subjects will receive co-administration of aspirin (100 mg/day) and clopidogrel (75 mg/day) for 12 months after randomization. The DAPT will last for 24 months after PCI.
12 Months DAPT
Procedure/SurgeryAll the subjects will receive aspirin (100 mg/day) + a placebo that is exactly the same in size, color, smell, taste and appearance as clopidogrel for 12 months after randomization. The DAPT will last for 12 months after PCI.
Major adverse cardiovascular and cerebrovascular event (MACCE)
The primary endpoint was major adverse cardiovascular and cerebrovascular event (MACCE), defined as a composite of all-cause death, non-fatal myocardial infarction or stroke.
BARC type 3 or 5 bleeding
Number of patients with a first occurrence of adjudicated BARC type 3 or 5 bleeding
Net adverse clinical event (NACE)
The key secondary endpoint was net adverse clinical event, defined as a composite of all-cause death, non-fatal myocardial infarction, stroke or Bleeding Academic Research Consortium (BARC)\] type 3 or 5 bleeding.
Cardiovascular death or myocardial infarction
Number of patients with a first occurrence of adjudicated composite of cardiovascular death or myocardial infarction.
All-cause death or myocardial infarction
Number of patients with a first occurrence of adjudicated composite of all-cause death or myocardial infarction.
Stent thrombosis
Number of patients with the adjudicated stent thrombosis.
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