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

30 aprile 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

2000

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Cina
      • Beijing, Cina
        • Fuwai Hospital, Chinese Academy of Medical Sciences
        • Contatto:
          • Lei Song
      • Beijing, Cina
        • Beijing Luhe Hospital Affiliated to Capital Medical University
        • Contatto:
          • Guangyao Zhai
      • Cangzhou, Cina
        • Cangzhou Central Hospital
        • Contatto:
          • Jun Zhang
      • Chengde, Cina
        • Chengde Medical College Affiliated Hospital
        • Contatto:
          • Ying Zhang
      • Chengdu, Cina
        • Sichuan Provincial People's Hospital
      • Dalian, Cina
        • The Second Affiliated Hospital of Dalian Medical University
        • Contatto:
          • Xin Zhao
      • Dalian, Cina
        • The First Affiliated Hospital of Dalian Medical University
      • Dalian, Cina
        • The Central Hospital Affiliated to Dalian University of Technology
        • Contatto:
          • Xiaoqun Zheng
      • Daqing, Cina
        • Daqing Oilfield General Hospital
        • Contatto:
          • Zhiqi Sun
      • Harbin, Cina
        • The Fourth Affiliated Hospital of Harbin Medical University
      • Hunan, Cina
        • The Third Xiangya Hospital of Central South University
        • Contatto:
          • Yu Cao
      • Jiamusi, Cina
        • Central Hospital of Jiamusi City
      • Jiamusi, Cina
        • The First Affiliated Hospital of Jiamusi University
        • Contatto:
          • Guangyuan Yang
      • Jilin, Cina
        • China-Japan Union Hospital of Jilin University
        • Contatto:
          • Yuquan He
      • Jilin, Cina
        • The First Hospital of Jilin University
        • Contatto:
          • Qian Tong
      • Jilin, Cina
        • Jilin Central Hospital
        • Contatto:
          • Yijun Shang
      • Jinan, Cina
        • Shandong Provincial Hospital
      • Jining, Cina
        • The Affiliated Hospital of Jining Medical University
        • Contatto:
          • Lijun Gan
      • Lanzhou, Cina
        • Lanzhou University First Hospital
      • Linyi, Cina
        • Linyi People's Hospital
        • Contatto:
          • Yanjin Wei
      • Mudanjiang, Cina
        • Mudanjiang Cardiovascular Hospital
        • Contatto:
          • Kai Liu
      • Nanyang, Cina
        • The First Affiliated Hospital of Nanyang Medical College
        • Contatto:
          • Ou Zhang
      • Qingdao, Cina
        • The Affiliated Hospital of Qingdao University
        • Contatto:
          • Zhexun Lian
      • Qiqihar, Cina
        • Qiqihar First Hospital
        • Contatto:
          • Jinhui Zhang
      • Qiqihar, Cina
        • The Second Affiliated Hospital of Qiqihar Medical University
      • Qiqihar, Cina
        • The Third Affiliated Hospital of Qiqihar Medical University
      • Shenyang, Cina
        • Shengjing Hospital Of China Medical University
        • Contatto:
          • Zhijun Sun
      • Shenyang, Cina
        • Liaoning Provincial People's Hospital
        • Contatto:
          • Bo Luan
      • Shenyang, Cina
        • The fourth Affiliated Hospital of China Medical University
        • Contatto:
          • Yuanzhe Jin
      • Shijia Zhuang, Cina
        • The Second Hospital of Hebei Medical University
      • Shijiazhuang, Cina
        • Hebei Provincial People's Hospital
        • Contatto:
          • Yi Dang
      • Suihua, Cina
        • Suihua First Hospital
        • Contatto:
          • Qiuye Yang
      • Taiyuan, Cina
        • General Hospital of Taiyuan Iron and Steel (Group) Co.
      • Taiyuan, Cina
        • Shanxi Provincial Cardiovascular Hospital
        • Contatto:
          • Zhulin Zhang
      • Tianjin, Cina
        • General Hospital of Tianjin Medical University
        • Contatto:
          • Qing Yang
      • Tianjin, Cina
        • Tianjin Chest Hospital
        • Contatto:
          • Chunjie Li
      • Tianjin, Cina
        • TEDA International Cardiovascular Hospital
        • Contatto:
          • Wenhua Lin
      • Wenzhou, Cina
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contatto:
          • Xueqiang Guan
      • Wuhan, Cina
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contatto:
          • Xiang Cheng
      • Wuhan, Cina
        • Wuhan Asia Heart Hospital
        • Contatto:
          • Hua Yan
      • Xi'an, Cina
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xinjiang, Cina
        • The first affiliated hospital of Xinjiang medical university
        • Contatto:
          • Xiang Ma
      • Xinjiang, Cina
        • People's Hospital of Xinjiang Uygur Autonomous Region
      • Yantai, Cina
        • Yantai Yuhuangding Hospital
      • Zhengzhou, Cina
        • The first affiliated hospital of Zhengzhou university
        • Contatto:
          • Jinying Zhang
      • Zhengzhou, Cina
        • Fuwai Huazhong Cardiovascular Hospital
      • Zunyi, Cina
        • Zunyi Medical University Affiliated Hospital
        • Contatto:
          • Ranzun Zhao

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Comparatore attivo: 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.
Procedura: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Target Lesion Failure(TLF)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
All-cause death
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Definite or probable in-stent thrombosis
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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.
Lasso di tempo: From randomization to the 12th month.
Exploratory endpoint:Functional sub research
From randomization to the 12th month.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Harbin Medical University

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 aprile 2026

Completamento primario (Stimato)

1 aprile 2029

Completamento dello studio (Stimato)

1 dicembre 2030

Date di iscrizione allo studio

Primo inviato

21 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 aprile 2026

Primo Inserito (Effettivo)

5 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KY2026-042

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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