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RECRUITING
NCT07567625
NA

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

Sponsor: Harbin Medical University

View on ClinicalTrials.gov

Summary

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.

Official title: Non-stenting Treatment Strategy for Acute Myocardial Infarction With Non-severe Stenosis: a Prospective, Multicenter, Open-label, Non-inferiority, Randomised Controlled Trial(EROSION IV)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2026-07-13

Completion Date

2030-12

Last Updated

2026-07-16

Healthy Volunteers

No

Interventions

DRUG

Guideline-recommended standard medical therapy alone

Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction

PROCEDURE

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.

Locations (48)

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Beijing Luhe Hospital Affiliated to Capital Medical University

Beijing, China

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, China

Cangzhou Central Hospital

Cangzhou, China

Chengde Medical College Affiliated Hospital

Chengde, China

Sichuan Provincial People's Hospital

Chengdu, China

The Central Hospital Affiliated to Dalian University of Technology

Dalian, China

The First Affiliated Hospital of Dalian Medical University

Dalian, China

The Second Affiliated Hospital of Dalian Medical University

Dalian, China

Daqing Oilfield General Hospital

Daqing, China

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, China

The Third Xiangya Hospital of Central South University

Hunan, China

Central Hospital of Jiamusi City

Jiamusi, China

The First Affiliated Hospital of Jiamusi University

Jiamusi, China

China-Japan Union Hospital of Jilin University

Jilin City, China

Jilin Central Hospital

Jilin City, China

The First Hospital of Jilin University

Jilin City, China

Shandong Provincial Hospital

Jinan, China

The Affiliated Hospital of Jining Medical University

Jining, China

Lanzhou University First Hospital

Lanzhou, China

Linyi People's Hospital

Linyi, China

Mudanjiang Cardiovascular Hospital

Mudanjiang, China

The First Affiliated Hospital of Nanyang Medical College

Nanyang, China

The Affiliated Hospital of Qingdao University

Qingdao, China

Qiqihar First Hospital

Qiqihar, China

The Second Affiliated Hospital of Qiqihar Medical University

Qiqihar, China

The Third Affiliated Hospital of Qiqihar Medical University

Qiqihar, China

Liaoning Provincial People's Hospital

Shenyang, China

Shengjing Hospital of China Medical University

Shenyang, China

The Fourth Affiliated Hospital of China Medical University

Shenyang, China

The Second Hospital of Hebei Medical University

Shijia Zhuang, China

Hebei Provincial People's Hospital

Shijiazhuang, China

Suihua First Hospital

Suihua, China

General Hospital of Taiyuan Iron and Steel (Group) Co.

Taiyuan, China

Shanxi Provincial Cardiovascular Hospital

Taiyuan, China

General Hospital of Tianjin Medical University

Tianjin, China

TEDA International Cardiovascular Hospital

Tianjin, China

Tianjin Chest Hospital

Tianjin, China

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Wuhan Asia Heart Hospital

Wuhan, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

People's Hospital of Xinjiang Uygur Autonomous Region

Xinjiang, China

The First Affiliated Hospital of Xinjiang Medical University

Xinjiang, China

Yantai Yuhuangding Hospital

Yantai, China

Fuwai Huazhong Cardiovascular Hospital

Zhengzhou, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Zunyi Medical University Affiliated Hospital

Zunyi, China