Guideline-recommended standard medical therapy alone
DrugDual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction
NCT Number: NCT07567625
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1.Clinical exclusion criteria:
2.Imaging exclusion criteria:
3.Functional sub study:
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.
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
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.
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
MACCE: defined as a composite endpoint consisting of all-cause death, myocardial infarction, stroke, and repeat revascularization.
Time frame: From 24 hours after surgery to discharge and the 12th month after discharge
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Safety endpoint
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Safety endpoint
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Safety endpoint
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Safety endpoint
Time frame: From randomization to the end of the study, median follow-up duration is 30 months.
Exploratory endpoint:Functional sub research
Time frame: From randomization to the 12th month.
Exploratory endpoint:Functional sub research
Contact information is provided by the study sponsor or research team.
Harbin Medical University
Other
Non-stenting Treatment Strategy for Acute Myocardial Infarction With Non-severe Stenosis: a Prospective, Multicenter, Open-label, Non-inferiority, Randomised Controlled Trial(EROSION IV)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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