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

14 de julho de 2026 atualizado por: Yu Bo, Harbin Medical University

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

2000

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • China
      • Beijing, China
        • Ainda não está recrutando
        • Fuwai Hospital, Chinese Academy of Medical Sciences
        • Contato:
          • Lei Song
      • Beijing, China
        • Ainda não está recrutando
        • Beijing Luhe Hospital Affiliated to Capital Medical University
        • Contato:
          • Guangyao Zhai
      • Cangzhou, China
        • Ainda não está recrutando
        • Cangzhou Central Hospital
        • Contato:
          • Jun Zhang
      • Chengde, China
        • Ainda não está recrutando
        • Chengde Medical College Affiliated Hospital
        • Contato:
          • Ying Zhang
      • Chengdu, China
        • Ainda não está recrutando
        • Sichuan Provincial People's Hospital
        • Contato:
          • Wenjie Tian
      • Dalian, China
        • Ainda não está recrutando
        • The First Affiliated Hospital of Dalian Medical University
        • Contato:
          • Bo Zhang
      • Dalian, China
        • Ainda não está recrutando
        • The Second Affiliated Hospital of Dalian Medical University
        • Contato:
          • Xin Zhao
      • Dalian, China
        • Ainda não está recrutando
        • The Central Hospital Affiliated to Dalian University of Technology
        • Contato:
          • Xiaoqun Zheng
      • Daqing, China
        • Ainda não está recrutando
        • Daqing Oilfield General Hospital
        • Contato:
          • Zhiqi Sun
      • Harbin, China
        • Ainda não está recrutando
        • The Fourth Affiliated Hospital of Harbin Medical University
        • Contato:
          • Wei Yang
      • Hunan, China
        • Ainda não está recrutando
        • The Third XIANGYA Hospital of Central South University
        • Contato:
          • Yu Cao
      • Jiamusi, China
        • Ainda não está recrutando
        • Central Hospital of Jiamusi City
        • Contato:
          • Zhiyuan Weng
      • Jiamusi, China
        • Ainda não está recrutando
        • The First Affiliated Hospital of Jiamusi University
        • Contato:
          • Guangyuan Yang
      • Jilin City, China
        • Ainda não está recrutando
        • China-Japan Union Hospital of Jilin University
        • Contato:
          • Yuquan He
      • Jilin City, China
        • Ainda não está recrutando
        • Jilin Central Hospital
        • Contato:
          • Yijun Shang
      • Jilin City, China
        • Ainda não está recrutando
        • The First Hospital of Jilin University
        • Contato:
          • Qian Tong
      • Jinan, China
        • Ainda não está recrutando
        • Shandong Provincial Hospital
        • Contato:
          • Haitao Yuan
      • Jining, China
        • Ainda não está recrutando
        • The Affiliated Hospital of Jining Medical University
        • Contato:
          • Lijun Gan
      • Lanzhou, China
        • Ainda não está recrutando
        • Lanzhou University First Hospital
        • Contato:
          • Ming Bai
      • Linyi, China
        • Ainda não está recrutando
        • Linyi People's Hospital
        • Contato:
          • Yanjin Wei
      • Mudanjiang, China
        • Ainda não está recrutando
        • Mudanjiang Cardiovascular Hospital
        • Contato:
          • Kai Liu
      • Nanyang, China
        • Ainda não está recrutando
        • The First Affiliated Hospital of Nanyang Medical College
        • Contato:
          • Ou Zhang
      • Qingdao, China
        • Ainda não está recrutando
        • The Affiliated Hospital of Qingdao University
        • Contato:
          • Zhexun Lian
      • Qiqihar, China
        • Ainda não está recrutando
        • Qiqihar First Hospital
        • Contato:
          • Jinhui Zhang
      • Qiqihar, China
        • Ainda não está recrutando
        • The Second Affiliated Hospital of Qiqihar Medical University
        • Contato:
          • Xiaojie Wu
      • Qiqihar, China
        • Ainda não está recrutando
        • The Third Affiliated Hospital of Qiqihar Medical University
        • Contato:
          • Haifeng Shao
      • Shenyang, China
        • Ainda não está recrutando
        • Shengjing Hospital of China Medical University
        • Contato:
          • Zhijun Sun
      • Shenyang, China
        • Ainda não está recrutando
        • The Fourth Affiliated Hospital of China Medical University
        • Contato:
          • Yuanzhe Jin
      • Shenyang, China
        • Ainda não está recrutando
        • Liaoning Provincial People's Hospital
        • Contato:
          • Bo Luan
      • Shijia Zhuang, China
        • Ainda não está recrutando
        • The Second Hospital of Hebei Medical University
        • Contato:
          • Xinshun Gu
      • Shijiazhuang, China
        • Ainda não está recrutando
        • Hebei Provincial People's Hospital
        • Contato:
          • Yi Dang
      • Suihua, China
        • Ainda não está recrutando
        • Suihua First Hospital
        • Contato:
          • Qiuye Yang
      • Taiyuan, China
        • Ainda não está recrutando
        • General Hospital of Taiyuan Iron and Steel (Group) Co.
        • Contato:
          • Huifeng Wang
      • Taiyuan, China
        • Ainda não está recrutando
        • Shanxi Provincial Cardiovascular Hospital
        • Contato:
          • Zhulin Zhang
      • Tianjin, China
        • Ainda não está recrutando
        • Tianjin Chest Hospital
        • Contato:
          • Chunjie Li
      • Tianjin, China
        • Ainda não está recrutando
        • Teda International Cardiovascular Hospital
        • Contato:
          • Wenhua Lin
      • Tianjin, China
        • Ainda não está recrutando
        • General Hospital of Tianjin Medical University
        • Contato:
          • Qing Yang
      • Wenzhou, China
        • Ainda não está recrutando
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contato:
          • Xueqiang Guan
      • Wuhan, China
        • Ainda não está recrutando
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contato:
          • Xiang Cheng
      • Wuhan, China
        • Ainda não está recrutando
        • Wuhan Asia Heart Hospital
        • Contato:
          • Hua Yan
      • Xi'an, China
        • Ainda não está recrutando
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contato:
          • Zuyi Yuan
      • Xinjiang, China
        • Ainda não está recrutando
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contato:
          • Xiang Ma
      • Xinjiang, China
        • Ainda não está recrutando
        • People's Hospital of Xinjiang Uygur Autonomous Region
        • Contato:
          • Yining Yang
      • Yantai, China
        • Ainda não está recrutando
        • Yantai YuHuangDing Hospital
        • Contato:
          • Faxin Ren
      • Zhengzhou, China
        • Ainda não está recrutando
        • The First Affiliated Hospital of Zhengzhou University
        • Contato:
          • Jinying Zhang
      • Zhengzhou, China
        • Ainda não está recrutando
        • Fuwai Huazhong Cardiovascular Hospital
        • Contato:
          • Chuanyu Gao
      • Zunyi, China
        • Ainda não está recrutando
        • Zunyi Medical University Affiliated Hospital
        • Contato:
          • Ranzun Zhao
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150086
        • Recrutamento
        • The Second Affiliated Hospital of Harbin Medical University
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Guideline-recommended standard medical therapy alone
Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.
Medicamento: Guideline-recommended standard medical therapy alone
Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction
Comparador Ativo: 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.
Procedimento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Target Lesion Failure(TLF)
Prazo: 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.
From randomization to the end of the study, median follow-up duration is 30 months.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
All-cause death
Prazo: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Cardiovascular death
Prazo: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Myocardial infarction (MI)
Prazo: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Target vessel myocardial infarction
Prazo: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Coronary Revascularization
Prazo: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Target vessel revascularization
Prazo: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Target lesion revascularization
Prazo: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Ischemia-driven target lesion revascularization
Prazo: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Stroke
Prazo: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Rehospitalization for unstable angina pectoris
Prazo: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Rehospitalization for heart failure
Prazo: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Major adverse cardiovascular and cerebrovascular events (MACCE)
Prazo: 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.
From randomization to the end of the study, median follow-up duration is 30 months.
Seattle Angina Questionnaire(SAQ)score
Prazo: From 24 hours after surgery to discharge and the 12th month after discharge
From 24 hours after surgery to discharge and the 12th month after discharge

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Definite or probable in-stent thrombosis
Prazo: From randomization to the end of the study, median follow-up duration is 30 months.
Safety endpoint
From randomization to the end of the study, median follow-up duration is 30 months.
Contrast-induced acute kidney injury(CI-AKI)
Prazo: From randomization to the end of the study, median follow-up duration is 30 months.
Safety endpoint
From randomization to the end of the study, median follow-up duration is 30 months.
Procedure-related myocardial infarction
Prazo: From randomization to the end of the study, median follow-up duration is 30 months.
Safety endpoint
From randomization to the end of the study, median follow-up duration is 30 months.
Bleeding Academic Research Consortium(BARC)type 3 and type 5 bleeding
Prazo: From randomization to the end of the study, median follow-up duration is 30 months.
Safety endpoint
From randomization to the end of the study, median follow-up duration is 30 months.
Microcirculation resistance index(IMR)to assess the incidence of coronary microvascular dysfunction (CMD)
Prazo: From randomization to the end of the study, median follow-up duration is 30 months.
Exploratory endpoint:Functional sub research
From randomization to the end of the study, median follow-up duration is 30 months.
The first occurrence of all-cause death and readmission due to heart failure within 12 months.
Prazo: From randomization to the 12th month.
Exploratory endpoint:Functional sub research
From randomization to the 12th month.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Harbin Medical University

Investigadores

  • Investigador principal: Bo Yu, Ph.D., The Second Affiliated Hospital of Harbin Medical University
  • Investigador principal: Jingbo Hou, Ph.D., The Second Affiliated Hospital of Harbin Medical University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

13 de julho de 2026

Conclusão Primária (Estimado)

1 de abril de 2029

Conclusão do estudo (Estimado)

1 de dezembro de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

21 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de abril de 2026

Primeira postagem (Real)

5 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • KY2026-042

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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