Non-stenting Treatment Strategy for Acute Myocardial Infarction With Non-severe Stenosis(EROSION IV) (NCT07567625) — China Trial Details

Condition(s) studied

Acute Myocardial Infarction (AMI)ST-Segment Elevation Myocardial Infarction(STEMI)Non-ST-Segment Elevation Myocardial Infarction(NSTEMI)

Investigational drug(s) / intervention(s)

Guideline-recommended standard medical therapy aloneDES implantation plus guideline-recommended standard medical therapy

Guideline-recommended standard medical therapy alone: Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction

DES implantation plus guideline-recommended standard medical therapy: DES implantation plus dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

No

Inclusion Criteria: 1. Male or female patients aged ≥18 years and ≤75 years; 2. Diagnosis of type 1 AMI, including STEMI (onset \<24 hours or 7-14 days) or NSTEMI; 3. After coronary angiography (CAG) ± thrombus aspiration, TIMI flow in the culprit vessel is restored to grade 3 and maintained for at least 5 minutes, with diameter stenosis (DS) \<70% at the culprit lesion (QCA); 4. Reference diameter of the culprit lesion \>2.5 mm and ≤4.0 mm; 5. Patients or a legally authorized representative must provide written Informed Consent prior to any study related procedure. Exclusion Criteria: 1.Clinical exclusion criteria: 1. Severe cardiac dysfunction (Killip/NYHA class ≥ 3) or LVEF \< 30%; 2. Cardiopulmonary resuscitation (CPR) performed at the onset of AMI; 3. Persistent hemodynamic or cardiac electrical instability after TIMI flow restoration; 4. Contraindication to antithrombotic drugs, or concurrent hemorrhagic diseases such as peptic ulcer or coagulation disorders; 5. Contraindication to contrast; 6. Severe renal dysfunction \[defined as eGFR ≤30 ml/min/1.73m² or Scr ≥2.0 mg/dL\] without regular dialysis (patients with chronic renal insufficiency on regular dialysis may be considered for enrollment); 7. Active liver disease, defined as known infectious, neoplastic, or metabolic liver lesions, with ALT and AST \>3× upper limit of normal (ULN); 8. Previous history of CABG or PCI for the culprit lesion; 9. Patients with other concurrent severe diseases and an expected life expectancy of \<1 year; 10. Pregnant or lactating women. Women of childbearing potential must use effective contraceptive measures during the study treatment period; 11. Inability to comply with the study protocol or other conditions deemed unsuitable for study participation by the investigator. 2.Imaging exclusion criteria: 1. Non-culprit lesion with DS ≥70% or planned revascularization; 2. Left main coronary artery lesion with DS ≥50%; 3. Culprit lesion is a true bifurcation lesion requiring a two-stent strategy; 4. Long lesion (planned stent length \>60 mm); 5. Culprit lesion with dissection, false lumen, or other conditions necessitating stent implantation; 6. Target lesion has undergone pre-treatment (such as balloon dilation, rotational atherectomy, etc.). 3.Functional sub study: 1. Individuals who are allergic to adenosine triphosphate (ATP) or any component in its preparations; 2. Second and third degree atrioventricular block, sick sinus syndrome (without artificial pacemaker protectors); 3. Patients with bronchial asthma.

Primary outcome measure(s)

Target Lesion Failure(TLF) — 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.

Trial sites (48)

Facility	City	Region	Status
The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang	Recruiting
Beijing Luhe Hospital Affiliated to Capital Medical University	Beijing	China	Not Yet Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences	Beijing	China	Not Yet Recruiting
Cangzhou Central Hospital	Cangzhou	China	Not Yet Recruiting
Chengde Medical College Affiliated Hospital	Chengde	China	Not Yet Recruiting
Sichuan Provincial People's Hospital	Chengdu	China	Not Yet Recruiting
The Central Hospital Affiliated to Dalian University of Technology	Dalian	China	Not Yet Recruiting
The First Affiliated Hospital of Dalian Medical University	Dalian	China	Not Yet Recruiting
The Second Affiliated Hospital of Dalian Medical University	Dalian	China	Not Yet Recruiting
Daqing Oilfield General Hospital	Daqing	China	Not Yet Recruiting
The Fourth Affiliated Hospital of Harbin Medical University	Harbin	China	Not Yet Recruiting
The Third Xiangya Hospital of Central South University	Hunan	China	Not Yet Recruiting
Central Hospital of Jiamusi City	Jiamusi	China	Not Yet Recruiting
The First Affiliated Hospital of Jiamusi University	Jiamusi	China	Not Yet Recruiting
China-Japan Union Hospital of Jilin University	Jilin City	China	Not Yet Recruiting
Jilin Central Hospital	Jilin City	China	Not Yet Recruiting
The First Hospital of Jilin University	Jilin City	China	Not Yet Recruiting
Shandong Provincial Hospital	Jinan	China	Not Yet Recruiting
The Affiliated Hospital of Jining Medical University	Jining	China	Not Yet Recruiting
Lanzhou University First Hospital	Lanzhou	China	Not Yet Recruiting
Linyi People's Hospital	Linyi	China	Not Yet Recruiting
Mudanjiang Cardiovascular Hospital	Mudanjiang	China	Not Yet Recruiting
The First Affiliated Hospital of Nanyang Medical College	Nanyang	China	Not Yet Recruiting
The Affiliated Hospital of Qingdao University	Qingdao	China	Not Yet Recruiting
Qiqihar First Hospital	Qiqihar	China	Not Yet Recruiting
The Second Affiliated Hospital of Qiqihar Medical University	Qiqihar	China	Not Yet Recruiting
The Third Affiliated Hospital of Qiqihar Medical University	Qiqihar	China	Not Yet Recruiting
Liaoning Provincial People's Hospital	Shenyang	China	Not Yet Recruiting
Shengjing Hospital of China Medical University	Shenyang	China	Not Yet Recruiting
The Fourth Affiliated Hospital of China Medical University	Shenyang	China	Not Yet Recruiting
The Second Hospital of Hebei Medical University	Shijia Zhuang	China	Not Yet Recruiting
Hebei Provincial People's Hospital	Shijiazhuang	China	Not Yet Recruiting
Suihua First Hospital	Suihua	China	Not Yet Recruiting
General Hospital of Taiyuan Iron and Steel (Group) Co.	Taiyuan	China	Not Yet Recruiting
Shanxi Provincial Cardiovascular Hospital	Taiyuan	China	Not Yet Recruiting
General Hospital of Tianjin Medical University	Tianjin	China	Not Yet Recruiting
TEDA International Cardiovascular Hospital	Tianjin	China	Not Yet Recruiting
Tianjin Chest Hospital	Tianjin	China	Not Yet Recruiting
The Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	China	Not Yet Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	China	Not Yet Recruiting

+ 8 more sites — see the full list on the official registry below.

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