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

14 juli 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

2000

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Guideline-recommended standard medical therapy alone
Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.
Läkemedel: Guideline-recommended standard medical therapy alone
Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction
Aktiv komparator: 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.
Procedur: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Target Lesion Failure(TLF)
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
All-cause death
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Definite or probable in-stent thrombosis
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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.
Tidsram: From randomization to the 12th month.
Exploratory endpoint:Functional sub research
From randomization to the 12th month.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Harbin Medical University

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

13 juli 2026

Primärt slutförande (Beräknad)

1 april 2029

Avslutad studie (Beräknad)

1 december 2030

Studieregistreringsdatum

Först inskickad

21 april 2026

Först inskickad som uppfyllde QC-kriterierna

30 april 2026

Första postat (Faktisk)

5 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • KY2026-042

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

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