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

14 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

2000

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Jingbo Hou, Ph.D.
  • Numéro de téléphone: 13303609625
  • E-mail: jingbohou@163.com

Sauvegarde des contacts de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Guideline-recommended standard medical therapy alone
Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.
Médicament: Guideline-recommended standard medical therapy alone
Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction
Comparateur actif: 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.
Procédure: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Target Lesion Failure(TLF)
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
All-cause death
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Definite or probable in-stent thrombosis
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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.
Délai: From randomization to the 12th month.
Exploratory endpoint:Functional sub research
From randomization to the 12th month.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Harbin Medical University

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

13 juillet 2026

Achèvement primaire (Estimé)

1 avril 2029

Achèvement de l'étude (Estimé)

1 décembre 2030

Dates d'inscription aux études

Première soumission

21 avril 2026

Première soumission répondant aux critères de contrôle qualité

30 avril 2026

Première publication (Réel)

5 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • KY2026-042

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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