This study is a prospective, multicenter, open-label, non-inferiority, randomized controlled trial. A total of 2,000 patients with STEMI (\<24 hours or 7-14 days) or NSTEMI will be recruited from at least 20 centers in China. Eligible patients must have residual DS \< 70% at the culprit lesion assessed by QCA, with optional thrombus aspiration, and TIMI flow of grade 3. Patients will be randomly assigned in a 1:1 ratio to the experimental group or the control group. The planned enrollment period is 36 months, and all patients will be followed up for at least 12 months after randomization, with continued follow-up until the end of the study. The primary outcome is the first occurrence of TLF after randomization, defined as the composite of cardiovascular death, target vessel myocardial infarction, ischemia-driven target lesion revascularization. The study aims to verify whether guideline-recommended standard medical therapy is non-inferior to DES implantation combined with guideline-recommended standard medical therapy in AMI patients with non-severe coronary artery stenosis. A total of 120 participants (60 in the experimental group and 60 in the control group) enrolled at the Second Affiliated Hospital of Harbin Medical University were included in the functional substudy. Using Abbott Pressure Wire™X pressure wire test functional indicators, and explore the incidence of coronary microvascular dysfunction (CMD) as assessed by the index of microcirculatory resistance (IMR) in two groups, and its impact on the rate of the composite endpoint of all-cause death and heart failure readmission occurring for the first time within 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,000
Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction
DES implantation plus dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGBeijing Luhe Hospital Affiliated to Capital Medical University
Beijing, China
NOT_YET_RECRUITINGFuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China
NOT_YET_RECRUITINGCangzhou Central Hospital
Cangzhou, China
Target Lesion Failure(TLF)
TLF is defined as a composite endpoint consisting of cardiovascular death, target vessel myocardial infarction and ischemia-driven target lesion revascularization.
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
All-cause death
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Cardiovascular death
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Myocardial infarction (MI)
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Target vessel myocardial infarction
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Coronary Revascularization
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Target vessel revascularization
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Target lesion revascularization
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Ischemia-driven target lesion revascularization
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Stroke
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Rehospitalization for unstable angina pectoris
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Rehospitalization for heart failure
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Major adverse cardiovascular and cerebrovascular events (MACCE)
MACCE: defined as a composite endpoint consisting of all-cause death, myocardial infarction, stroke, and repeat revascularization.
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Seattle Angina Questionnaire(SAQ)score
Time frame: From 24 hours after surgery to discharge and the 12th month after discharge
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Chengde Medical College Affiliated Hospital
Chengde, China
NOT_YET_RECRUITINGSichuan Provincial People's Hospital
Chengdu, China
NOT_YET_RECRUITINGThe Central Hospital Affiliated to Dalian University of Technology
Dalian, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Dalian Medical University
Dalian, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Dalian Medical University
Dalian, China
NOT_YET_RECRUITINGDaqing Oilfield General Hospital
Daqing, China
NOT_YET_RECRUITING...and 38 more locations