Effective ReperfusiOn Strategy for Patients With ST-segment Elevation Myocardial Infarction Guided by Optical Coherence Tomography Versus ANgiography (EROSION III): a Multicenter, Randomized Controlled Trial
Sponsor study identifier
interventional
246
1 country
12
Study Start
December 21, 2017
Actual (reported)Primary Completion
January 2, 2020
Actual (reported)Study Completion
December 24, 2020
Actual (reported)Brief Summary: This study is a prospective, multicenter, randomized, controlled trial aimed to compare the reperfusion strategy and clinical outcomes of STEMI patients treated by angiography-guided vs. OCT-guided PCI. Patients presenting STEMI with coronary artery diameter stenosis ≤70% and TIMI blood flow grade 3 at index or after thrombus aspiration are randomly assigned to either an OCT-guided group or an angiography-guided group. In OCT-guided group, stent implantation or conservative medical treatment is determined based on OCT findings. Conservative non-stenting strategy will be recommended in those with culprit plaque erosions, certain ruptures without dissection and hematoma, SCAD without obstructive stenosis. In the angiography-guided group, reperfusion strategy is decided by the operators according to the local practice. The rate of stenting during primary PCI and clinical outcomes at 1-month and 1-year are collected.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 24, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 21, 2017
Actual (reported)June 15, 2018
Actual (reported)June 27, 2018
Actual (reported)January 2, 2020
Actual (reported)December 24, 2020
Actual (reported)Primary effective endpoint of OCT-guided reperfusion strategy (powered)
Patient-level rate of stent implantation between the two groups
Immediate after primary PCI
Primary safety endpoint of OCT-guided reperfusion strategy
The incidence of recurrent myocardial ischemic events (unstable angina-induced rehospitalization, recurrent myocardial infarction, target lesion revascularization) or cardiac death.
Within 1 month
Incidence of cardiocerebrovascular events
Within 1 year
Incidence of heart failure event
Within 1 year
Detailed methods of OCT examination are the same as above. Whether stenting or not will be decided by the operators according to the underlying mechanisms of culprit lesions. If stenting, OCT will be used to guide and optimize the whole process of PCI. Patients will be treated with dual antiplatelet therapy (aspirin+ticagrelor or aspirin+clopidogrel) for at least 12 months.
Detailed methods of angiography examination are the same as above. Whether stenting or not and the whole process of PCI will be decided by the operators according to the current treatment standard of angiography. Patients will be treated with dual antiplatelet therapy (aspirin+ticagrelor or aspirin+clopidogrel) for at least 12 months.
Optical coherence tomography will be used to detect the detailed characteristics of culprit lesion and to decide and optimize the reperfusion strategy according to the established algorithm in the protocol.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Daqing Oil Field Hospital
Daqing, Heilongjiang, China
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Jia H, Dai J, He L, Xu Y, Shi Y, Zhao L, Sun Z, Liu Y, Weng Z, Feng X, Zhang D, Chen T, Zhang X, Li L, Xu Y, Wu Y, Yang Y, Wang C, Li L, Li J, Hou J, Liu B, Mintz GS, Yu B. EROSION III: A Multicenter RCT of OCT-Guided Reperfusion in STEMI With Early Infarct Artery Patency. JACC Cardiovasc Interv. 2022 Apr 25;15(8):846-856. doi: 10.1016/j.jcin.2022.01.298. Epub 2022 Mar 30.
Bo Yu
The Second Affiliated Hospital of Harbin Medical University
Bin Liu
Second Hospital of Jilin University
Jianping Li
Peking University First Hospital
Yanqing Wu
Second Affiliated Hospital of Nanchang University
246 participants (actual enrollment reported by the registry).
First Submitted
June 15, 2018
First Posted
June 27, 2018
Study Start
December 21, 2017
Actual (reported)Contact the study team to confirm eligibility.
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Hospital of Jilin University
Jilin City, Jilin, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Ling Li
The First Affiliated Hospital of Zhengzhou University
Chunmei Wang
Beijing Anzhen Hospital
Yin Liu
Tianjin Chest Hospital
Dajun Yuan
The Second Affilated Hospital of Dalian Medical University
Zhiqi Sun
Daqing Oil Field Hospital
Yining Yang
First Affiliated Hospital of Xinjiang Medical University
Xinshun Gu
The Second Hospital of Hebei Medical University
Lang Li
First Affiliated Hospital of Guangxi Medical University
Primary Completion
January 2, 2020
Actual (reported)Study Completion
December 24, 2020
Actual (reported)Last Updated
August 19, 2021
Record last verified: 2021-08
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Source: ClinicalTrials.gov.
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