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Acute Myocardial Infarction (AMI)NCT07567625

Non-stenting Treatment Strategy for Acute Myocardial Infarction With Non-severe Stenosis(EROSION IV)

A study testing Guideline-recommended standard medical therapy alone and DES implantation plus guideline-recommended standard medical therapy in people with Acute Myocardial Infarction (AMI) and ST-Segment Elevation Myocardial Infarction(STEMI), run by Harbin Medical University at 48 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Guideline-recommended standard medical therapy alone and DES implantation plus guideline-recommended standard medical therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
48 sitesChina
Study dates
13 Jul 2026to Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients aged ≥18 years and ≤75 years;
  • Diagnosis of type 1 AMI, including STEMI (onset <24 hours or 7-14 days) or NSTEMI;
  • 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);
  • Reference diameter of the culprit lesion >2.5 mm and ≤4.0 mm;
  • Patients or a legally authorized representative must provide written Informed Consent prior to any study related procedure.

Who cannot join

  • 1.Clinical exclusion criteria:
  • Severe cardiac dysfunction (Killip/NYHA class ≥ 3) or LVEF < 30%;
  • Cardiopulmonary resuscitation (CPR) performed at the onset of AMI;
  • Persistent hemodynamic or cardiac electrical instability after TIMI flow restoration;
  • Contraindication to antithrombotic drugs, or concurrent hemorrhagic diseases such as peptic ulcer or coagulation disorders;
  • Contraindication to contrast;
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  • 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);
  • Active liver disease, defined as known infectious, neoplastic, or metabolic liver lesions, with ALT and AST >3× upper limit of normal (ULN);
  • Previous history of CABG or PCI for the culprit lesion;
  • Patients with other concurrent severe diseases and an expected life expectancy of <1 year;
  • Pregnant or lactating women. Women of childbearing potential must use effective contraceptive measures during the study treatment period;
  • Inability to comply with the study protocol or other conditions deemed unsuitable for study participation by the investigator.
  • 2.Imaging exclusion criteria:
  • Non-culprit lesion with DS ≥70% or planned revascularization;
  • Left main coronary artery lesion with DS ≥50%;
  • Culprit lesion is a true bifurcation lesion requiring a two-stent strategy;
  • Long lesion (planned stent length >60 mm);
  • Culprit lesion with dissection, false lumen, or other conditions necessitating stent implantation;
  • Target lesion has undergone pre-treatment (such as balloon dilation, rotational atherectomy, etc.).
  • 3.Functional sub study:
  • Individuals who are allergic to adenosine triphosphate (ATP) or any component in its preparations;
  • Second and third degree atrioventricular block, sick sinus syndrome (without artificial pacemaker protectors);
  • Patients with bronchial asthma.

Trial locations and contacts

48 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jingbo Hou, Ph.D. contact

13303609625

jingbohou@163.com

Bo Yu, Ph.D. contact

yubodr@163.com

48 sites in 1 country

China48 sites, 48 recruiting

  • Beijing Luhe Hospital Affiliated to Capital Medical University

    Beijing

    Guangyao Zhai

    Not yet recruiting

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing

    Lei Song

    Not yet recruiting

  • Cangzhou Central Hospital

    Cangzhou

    Jun Zhang

    Not yet recruiting

  • Chengde Medical College Affiliated Hospital

    Chengde

    Ying Zhang

    Not yet recruiting

  • Sichuan Provincial People's Hospital

    Chengdu

    Wenjie Tian

    Not yet recruiting

  • The Central Hospital Affiliated to Dalian University of Technology

    Dalian

    Xiaoqun Zheng

    Not yet recruiting

  • The First Affiliated Hospital of Dalian Medical University

    Dalian

    Bo Zhang

    Not yet recruiting

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian

    Xin Zhao

    Not yet recruiting

  • Daqing Oilfield General Hospital

    Daqing

    Zhiqi Sun

    Not yet recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086

    Jingbo Hou, M.D., 8613303609625, jingbohou@163.com

    Recruiting

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin

    Wei Yang

    Not yet recruiting

  • The Third Xiangya Hospital of Central South University

    Hunan

    Yu Cao

    Not yet recruiting

  • Central Hospital of Jiamusi City

    Jiamusi

    Zhiyuan Weng

    Not yet recruiting

  • The First Affiliated Hospital of Jiamusi University

    Jiamusi

    Guangyuan Yang

    Not yet recruiting

  • China-Japan Union Hospital of Jilin University

    Jilin City

    Yuquan He

    Not yet recruiting

  • Jilin Central Hospital

    Jilin City

    Yijun Shang

    Not yet recruiting

  • The First Hospital of Jilin University

    Jilin City

    Qian Tong

    Not yet recruiting

  • Shandong Provincial Hospital

    Jinan

    Haitao Yuan

    Not yet recruiting

  • The Affiliated Hospital of Jining Medical University

    Jining

    Lijun Gan

    Not yet recruiting

  • Lanzhou University First Hospital

    Lanzhou

    Ming Bai

    Not yet recruiting

  • Linyi People's Hospital

    Linyi

    Yanjin Wei

    Not yet recruiting

  • Mudanjiang Cardiovascular Hospital

    Mudanjiang

    Kai Liu

    Not yet recruiting

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang

    Ou Zhang

    Not yet recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao

    Zhexun Lian

    Not yet recruiting

  • Qiqihar First Hospital

    Qiqihar

    Jinhui Zhang

    Not yet recruiting

  • The Second Affiliated Hospital of Qiqihar Medical University

    Qiqihar

    Xiaojie Wu

    Not yet recruiting

  • The Third Affiliated Hospital of Qiqihar Medical University

    Qiqihar

    Haifeng Shao

    Not yet recruiting

  • Liaoning Provincial People's Hospital

    Shenyang

    Bo Luan

    Not yet recruiting

  • Shengjing Hospital of China Medical University

    Shenyang

    Zhijun Sun

    Not yet recruiting

  • The Fourth Affiliated Hospital of China Medical University

    Shenyang

    Yuanzhe Jin

    Not yet recruiting

  • The Second Hospital of Hebei Medical University

    Shijia Zhuang

    Xinshun Gu

    Not yet recruiting

  • Hebei Provincial People's Hospital

    Shijiazhuang

    Yi Dang

    Not yet recruiting

  • Suihua First Hospital

    Suihua

    Qiuye Yang

    Not yet recruiting

  • General Hospital of Taiyuan Iron and Steel (Group) Co.

    Taiyuan

    Huifeng Wang

    Not yet recruiting

  • Shanxi Provincial Cardiovascular Hospital

    Taiyuan

    Zhulin Zhang

    Not yet recruiting

  • General Hospital of Tianjin Medical University

    Tianjin

    Qing Yang

    Not yet recruiting

  • TEDA International Cardiovascular Hospital

    Tianjin

    Wenhua Lin

    Not yet recruiting

  • Tianjin Chest Hospital

    Tianjin

    Chunjie Li

    Not yet recruiting

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou

    Xueqiang Guan

    Not yet recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan

    Xiang Cheng

    Not yet recruiting

  • Wuhan Asia Heart Hospital

    Wuhan

    Hua Yan

    Not yet recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

    Zuyi Yuan

    Not yet recruiting

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Xinjiang

    Yining Yang

    Not yet recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Xinjiang

    Xiang Ma

    Not yet recruiting

  • Yantai Yuhuangding Hospital

    Yantai

    Faxin Ren

    Not yet recruiting

  • Fuwai Huazhong Cardiovascular Hospital

    Zhengzhou

    Chuanyu Gao

    Not yet recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Jinying Zhang

    Not yet recruiting

  • Zunyi Medical University Affiliated Hospital

    Zunyi

    Ranzun Zhao

    Not yet recruiting

Other trials in China

About this study

Official title: Non-stenting Treatment Strategy for Acute Myocardial Infarction With Non-severe Stenosis: a Prospective, Multicenter, Open-label, Non-inferiority, Randomised Controlled Trial(EROSION IV)

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.

Being tested
Guideline-recommended standard medical therapy alone, DES implantation plus guideline-recommended standard medical therapy
Keywords
AMI, DES, TLF, IMR, OCT
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guideline-recommended standard medical therapy aloneDrug

    Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction

  • DES implantation plus guideline-recommended standard medical therapyProcedure or surgery

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

Study groups in NCT07567625
Study groupRoleWhat they receive
Guideline-recommended standard medical therapy aloneExperimentalDual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.
Receives: Drug: Guideline-recommended standard medical therapy alone
DES implantation plus guideline-recommended standard medical therapyActive comparatorDES implantation plus dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.
Receives: Procedure: DES implantation plus guideline-recommended standard medical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From randomization to the end of the study, median follow-up duration is 30 months.

Secondary outcomes (13)

  1. All-cause death

    Measured: From randomization to the end of the study, median follow-up duration is 30 months.

  2. Cardiovascular death

    Measured: From randomization to the end of the study, median follow-up duration is 30 months.

  3. Myocardial infarction (MI)

    Measured: From randomization to the end of the study, median follow-up duration is 30 months.

  4. Target vessel myocardial infarction

    Measured: From randomization to the end of the study, median follow-up duration is 30 months.

  5. Coronary Revascularization

    Measured: From randomization to the end of the study, median follow-up duration is 30 months.

  6. Target vessel revascularization

    Measured: From randomization to the end of the study, median follow-up duration is 30 months.

  7. Target lesion revascularization

    Measured: From randomization to the end of the study, median follow-up duration is 30 months.

  8. Ischemia-driven target lesion revascularization

    Measured: From randomization to the end of the study, median follow-up duration is 30 months.

  9. Stroke

    Measured: From randomization to the end of the study, median follow-up duration is 30 months.

  10. Rehospitalization for unstable angina pectoris

    Measured: From randomization to the end of the study, median follow-up duration is 30 months.

  11. Rehospitalization for heart failure

    Measured: From randomization to the end of the study, median follow-up duration is 30 months.

  12. Major adverse cardiovascular and cerebrovascular events (MACCE)

    MACCE: defined as a composite endpoint consisting of all-cause death, myocardial infarction, stroke, and repeat revascularization.

    Measured: From randomization to the end of the study, median follow-up duration is 30 months.

  13. Seattle Angina Questionnaire(SAQ)score

    Measured: From 24 hours after surgery to discharge and the 12th month after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2026
  2. Study start13 Jul 2026
  3. Primary completionApr 2029 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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. Patients will be randomly assigned in a 1:1 ratio to the experimental group or the control group .
Masking
None (open label)
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07567625
Sponsor's protocol ID
KY2026-042
Status last verified
Jul 2026
First submitted
21 Apr 2026
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Guideline-recommended standard medical therapy alone and DES implantation plus guideline-recommended standard medical therapy in people with Acute Myocardial Infarction (AMI) and ST-Segment Elevation Myocardial Infarction(STEMI), run by Harbin Medical University at 48 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jingbo Hou, Ph.D. (13303609625, jingbohou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Lesion Failure(TLF) (time frame: From randomization to the end of the study, median follow-up duration is 30 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07567625.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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