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

14 de julio de 2026 actualizado 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

2000

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Jingbo Hou, Ph.D.
  • Número de teléfono: 13303609625
  • Correo electrónico: jingbohou@163.com

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Porcelana
      • Beijing, Porcelana
        • Aún no reclutando
        • Fuwai Hospital, Chinese Academy of Medical Sciences
        • Contacto:
          • Lei Song
      • Beijing, Porcelana
        • Aún no reclutando
        • Beijing Luhe Hospital Affiliated to Capital Medical University
        • Contacto:
          • Guangyao Zhai
      • Cangzhou, Porcelana
        • Aún no reclutando
        • Cangzhou Central Hospital
        • Contacto:
          • Jun Zhang
      • Chengde, Porcelana
        • Aún no reclutando
        • Chengde Medical College Affiliated Hospital
        • Contacto:
          • Ying Zhang
      • Chengdu, Porcelana
        • Aún no reclutando
        • Sichuan Provincial People's Hospital
        • Contacto:
          • Wenjie Tian
      • Dalian, Porcelana
        • Aún no reclutando
        • The First Affiliated Hospital of Dalian Medical University
        • Contacto:
          • Bo Zhang
      • Dalian, Porcelana
        • Aún no reclutando
        • The Second Affiliated Hospital of Dalian Medical University
        • Contacto:
          • Xin Zhao
      • Dalian, Porcelana
        • Aún no reclutando
        • The Central Hospital Affiliated to Dalian University of Technology
        • Contacto:
          • Xiaoqun Zheng
      • Daqing, Porcelana
        • Aún no reclutando
        • Daqing Oilfield General Hospital
        • Contacto:
          • Zhiqi Sun
      • Harbin, Porcelana
        • Aún no reclutando
        • The Fourth Affiliated Hospital of Harbin Medical University
        • Contacto:
          • Wei Yang
      • Hunan, Porcelana
        • Aún no reclutando
        • The Third XIANGYA Hospital of Central South University
        • Contacto:
          • Yu Cao
      • Jiamusi, Porcelana
        • Aún no reclutando
        • Central Hospital of Jiamusi City
        • Contacto:
          • Zhiyuan Weng
      • Jiamusi, Porcelana
        • Aún no reclutando
        • The First Affiliated Hospital of Jiamusi University
        • Contacto:
          • Guangyuan Yang
      • Jilin City, Porcelana
        • Aún no reclutando
        • China-Japan Union Hospital of Jilin University
        • Contacto:
          • Yuquan He
      • Jilin City, Porcelana
        • Aún no reclutando
        • Jilin Central Hospital
        • Contacto:
          • Yijun Shang
      • Jilin City, Porcelana
        • Aún no reclutando
        • The First Hospital of Jilin University
        • Contacto:
          • Qian Tong
      • Jinan, Porcelana
        • Aún no reclutando
        • Shandong Provincial Hospital
        • Contacto:
          • Haitao Yuan
      • Jining, Porcelana
        • Aún no reclutando
        • The Affiliated Hospital of Jining Medical University
        • Contacto:
          • Lijun Gan
      • Lanzhou, Porcelana
        • Aún no reclutando
        • Lanzhou University First Hospital
        • Contacto:
          • Ming Bai
      • Linyi, Porcelana
        • Aún no reclutando
        • Linyi People's Hospital
        • Contacto:
          • Yanjin Wei
      • Mudanjiang, Porcelana
        • Aún no reclutando
        • Mudanjiang Cardiovascular Hospital
        • Contacto:
          • Kai Liu
      • Nanyang, Porcelana
        • Aún no reclutando
        • The First Affiliated Hospital of Nanyang Medical College
        • Contacto:
          • Ou Zhang
      • Qingdao, Porcelana
        • Aún no reclutando
        • The Affiliated Hospital of Qingdao University
        • Contacto:
          • Zhexun Lian
      • Qiqihar, Porcelana
        • Aún no reclutando
        • Qiqihar First Hospital
        • Contacto:
          • Jinhui Zhang
      • Qiqihar, Porcelana
        • Aún no reclutando
        • The Second Affiliated Hospital of Qiqihar Medical University
        • Contacto:
          • Xiaojie Wu
      • Qiqihar, Porcelana
        • Aún no reclutando
        • The Third Affiliated Hospital of Qiqihar Medical University
        • Contacto:
          • Haifeng Shao
      • Shenyang, Porcelana
        • Aún no reclutando
        • Shengjing Hospital of China Medical University
        • Contacto:
          • Zhijun Sun
      • Shenyang, Porcelana
        • Aún no reclutando
        • The Fourth Affiliated Hospital of China Medical University
        • Contacto:
          • Yuanzhe Jin
      • Shenyang, Porcelana
        • Aún no reclutando
        • Liaoning Provincial People's Hospital
        • Contacto:
          • Bo Luan
      • Shijia Zhuang, Porcelana
        • Aún no reclutando
        • The Second Hospital of Hebei Medical University
        • Contacto:
          • Xinshun Gu
      • Shijiazhuang, Porcelana
        • Aún no reclutando
        • Hebei Provincial People's Hospital
        • Contacto:
          • Yi Dang
      • Suihua, Porcelana
        • Aún no reclutando
        • Suihua First Hospital
        • Contacto:
          • Qiuye Yang
      • Taiyuan, Porcelana
        • Aún no reclutando
        • General Hospital of Taiyuan Iron and Steel (Group) Co.
        • Contacto:
          • Huifeng Wang
      • Taiyuan, Porcelana
        • Aún no reclutando
        • Shanxi Provincial Cardiovascular Hospital
        • Contacto:
          • Zhulin Zhang
      • Tianjin, Porcelana
        • Aún no reclutando
        • Tianjin Chest Hospital
        • Contacto:
          • Chunjie Li
      • Tianjin, Porcelana
        • Aún no reclutando
        • Teda International Cardiovascular Hospital
        • Contacto:
          • Wenhua Lin
      • Tianjin, Porcelana
        • Aún no reclutando
        • General Hospital of Tianjin Medical University
        • Contacto:
          • Qing Yang
      • Wenzhou, Porcelana
        • Aún no reclutando
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contacto:
          • Xueqiang Guan
      • Wuhan, Porcelana
        • Aún no reclutando
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contacto:
          • Xiang Cheng
      • Wuhan, Porcelana
        • Aún no reclutando
        • Wuhan Asia Heart Hospital
        • Contacto:
          • Hua Yan
      • Xi'an, Porcelana
        • Aún no reclutando
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contacto:
          • Zuyi Yuan
      • Xinjiang, Porcelana
        • Aún no reclutando
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contacto:
          • Xiang Ma
      • Xinjiang, Porcelana
        • Aún no reclutando
        • People's Hospital of Xinjiang Uygur Autonomous Region
        • Contacto:
          • Yining Yang
      • Yantai, Porcelana
        • Aún no reclutando
        • Yantai YuHuangDing Hospital
        • Contacto:
          • Faxin Ren
      • Zhengzhou, Porcelana
        • Aún no reclutando
        • The First Affiliated Hospital of Zhengzhou University
        • Contacto:
          • Jinying Zhang
      • Zhengzhou, Porcelana
        • Aún no reclutando
        • Fuwai Huazhong Cardiovascular Hospital
        • Contacto:
          • Chuanyu Gao
      • Zunyi, Porcelana
        • Aún no reclutando
        • Zunyi Medical University Affiliated Hospital
        • Contacto:
          • Ranzun Zhao
    • Heilongjiang
      • Harbin, Heilongjiang, Porcelana, 150086
        • Reclutamiento
        • The Second Affiliated Hospital of Harbin Medical University
        • Contacto:
          • Jingbo Hou, M.D.
          • Número de teléfono: 8613303609625
          • Correo electrónico: jingbohou@163.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Guideline-recommended standard medical therapy alone
Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.
Droga: Guideline-recommended standard medical therapy alone
Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction
Comparador activo: 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.
Procedimiento: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Target Lesion Failure(TLF)
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
All-cause death
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Definite or probable in-stent thrombosis
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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.
Periodo de tiempo: From randomization to the 12th month.
Exploratory endpoint:Functional sub research
From randomization to the 12th month.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

13 de julio de 2026

Finalización primaria (Estimado)

1 de abril de 2029

Finalización del estudio (Estimado)

1 de diciembre de 2030

Fechas de registro del estudio

Enviado por primera vez

21 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de abril de 2026

Publicado por primera vez (Actual)

5 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • KY2026-042

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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