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NCT06360458Active, not recruitingPhase 3

Methylprednisolone Adjunctive to Endovascular Thrombectomy for Stroke

Methylprednisolone as Adjunct to Endovascular Thrombectomy for Patients With Acute Ischemic Strokes With Large Infarct: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial (MIRACLE)

Source: ClinicalTrials.gov · Last updated 3 Dec 2025

Brief summary (registry, in English)

The efficacy and safety of methylprednisolone in acute ischemic stroke patients with large infarct cores (ASPECTS score \< 6 or infarct volume ≥50 mL) due to anterior circulation large vessel occlusion have not been clearly established. This is a multi-center, randomized, double-blind, placebo-controlled trial to investigate early combination therapy with methylprednisolone for reperfusion in acute large core infarction.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
928 (actual)
First submitted
7 Apr 2024
Start date
1 Aug 2024
Primary completion date
30 Sept 2025
Lead sponsor
Wan-Jin Chen
Diseases
Stroke
NCT number
NCT06360458

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 928
  • From 1 Aug 2024 to the primary completion date, 30 Sept 2025
  • 99 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Intracranial hemorrhage confirmed by cranial CT or MRI.
  • Allergic to contrast agents or glucocorticoids.
  • Bleeding history (gastrointestinal and urinary tract bleeding) in recent 1 month.
  • Life expectancy due to any advanced disease \< 6 months.
  • Systemic infectious disease.

Lab values

  • Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate \< 30 ml/min or serum creatinine \> 220 umol/L \[2.5 mg/ dL\]).

Other

  • mRS score \> 2 before onset.
  • Pregnant or lactating women.
  • Participating in other clinical trials.
  • The artery is tortuous so that the thrombectomy device cannot reach the target vessel.
  • Follow-up is not expected to be completed.
  • Intracranial aneurysm and arteriovenous malformation.
  • Brain tumors with imaging mass effect.

Who the study is looking for

  • Age ≥ 18 years.
  • The time from onset to randomization was within 12 hours.
  • Anterior circulation ischemic stroke was preliminarily determined according to clinical symptoms or imaging examination.
  • Occlusion of the intracranial internal carotid artery, the M1- or M2-segment of the middle cerebral artery by confirmed by CT angiography (CTA), MR angiography (MRA), or digital subtraction angiography (DSA).
  • Baseline National Institutes of Health Stroke Scale (NIHSS) ≥ 6.
  • Baseline Alberta Stroke Program Early CT Score (ASPECTS) \< 6 (based on non-contrast CT or MRI) and/or core infarct volume ≥ 50 ml (based on CTP with rCBF \< 30%).
  • Planned treatment with endovascular thrombectomy (EVT).
  • Informed consent obtained from patients or their legal representatives.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (99)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Anxi County Hospital
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AnxiChinaUnknown status
Anxi Hospital of Traditional Chinese Medicine
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AnxiChinaUnknown status
Baotou Central Hospital
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BaotouChinaUnknown status
Biyan People's Hospital
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BiyangChinaUnknown status
Bozhou People's Hospital
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BoleChinaUnknown status
Chongzhou People's Hospital
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ChengduChinaUnknown status
The Central Hospital of Enshi Tujia And Miao Automomous Prefecture
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EnshiChinaUnknown status
Ezhou Central Hospital
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EzhouChinaUnknown status
Fuqing City Hospital of Fujian
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FuqingChinaUnknown status
Fuzhou University Affiliated Provincial Hospital
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FuzhouChinaUnknown status
900th Hospital of PLA Joint Logistic Support Force
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FuzhouChinaUnknown status
Department of Neurology, First Affiliated Hospital Fujian Medical University
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FuzhouChinaUnknown status
Union Hospital Affiliated to Fujian Medical University
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FuzhouChinaUnknown status
The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine
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FuzhouChinaUnknown status
First Affiliated Hospital Of Gannan Medical University
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GanzhouChinaUnknown status
Ganzhou People's Hospital, Ganzhou (G.Z.)
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GanzhouChinaUnknown status
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
Guangzhou First People's Hospital
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GuangzhouChinaUnknown status
Gulin County People's Hospital
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GulinChinaUnknown status
The Second Affiliated Hospital of Hainan Medical University
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HaikouChinaUnknown status
The First Affiliated Hospital of Hainan Medical University
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HaikouChinaUnknown status
The First Affiliated Hospital of USTC
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HefeiChinaUnknown status
Hefei First People's Hospital
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HefeiChinaUnknown status
Huanggang Central Hospital
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HuanggangChinaUnknown status
Qichun People's Hospital
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HuanggangChinaUnknown status
Huangshi Central Hospital
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HuangshiChinaUnknown status
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
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JinanChinaUnknown status
Jinan Central Hospital Affiliated to Shandong First Medical University
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JinanChinaUnknown status
Jingdezhen First People's Hospital
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JingdezhenChinaUnknown status
Yangtze University Affiliated Hospital
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JingzhouChinaUnknown status
Jingzhou Hospital Affiliated to Yangtze University
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JingzhouChinaUnknown status
Jiujiang University Affiliated Hospital
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JiujiangChinaUnknown status
The First People's Hospital of Jiujiang
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JiujiangChinaUnknown status
Gansu Province Central Hospital
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LanzhouChinaUnknown status
Liaocheng People's Hospital
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LiaochengChinaUnknown status
Liaocheng Third People's Hospital
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LiaochengChinaUnknown status
Lichuan City Ethnic Traditional Chinese Medical Hospital
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LichuanChinaUnknown status
Longyan First Affiliated Hospital of Fujian Medical University
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LongyanChinaUnknown status
Maoming Hospital of Traditional Chinese Medicine
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MaomingChinaUnknown status
Maoming people's hospital
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MaomingChinaUnknown status
Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China
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MianyangChinaUnknown status
Mianyang 404 Hospital
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MianyangChinaUnknown status
Jiangxi Provincial People's Hospital
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NanchangChinaUnknown status
The First Affiliated Hospital, Jiangxi Medical College, Nanchang University
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NanchangChinaUnknown status
Affiliated Hospital of North Sichuan Medical College
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NanchongChinaUnknown status
Nanping First Hospital
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NanpingChinaUnknown status
Ningde Municipal Hospital, Ningde Normal University
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NingdeChinaUnknown status
Mindong Hospital
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NingdeChinaUnknown status
Putian University Affiliated Hospital
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PutianChinaUnknown status
The First Hospital of Putian City
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PutianChinaUnknown status
The Affiliated Hospital of Qingdao Univercity
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QingdaoChinaUnknown status
The First People's Hospital of Qingzhen
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QingzhenChinaUnknown status
The Second Affiliated Hospital of Fujian Medical University
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QuanzhouChinaUnknown status
The 910th Hospital of the Joint Logistics Support Force of the Chinese PLA
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QuanzhouChinaUnknown status
Quanzhou First Hospital Affiliated to Fujian Medical University
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QuanzhouChinaUnknown status
Qujing NO.1 Hospital
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QujingChinaUnknown status
SanMing First Hospital
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SanmingChinaUnknown status
Ruijin Hospital Shanghai Jiaotong University School of Medicine
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ShanghaiChinaUnknown status
Shantou Central Hospital
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ShantouChinaUnknown status
Shaowu Municiple Hospital
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ShaowuChinaUnknown status
Taihe Hospital Affiliated to Hubei University of Medicine
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ShiyanChinaUnknown status
Shiyan Hospital of Integrated Traditional and Western Medicine
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ShiyanChinaUnknown status
Shiyan Renmin Hospital
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ShiyanChinaUnknown status
Suining Central Hospital
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SuiningChinaUnknown status
The Second Affiliated Hospital of Shandong First Medical University
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Tai’anChinaUnknown status
Taihe County People's Hospital
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Taihe ChengguanzhenChinaUnknown status
Shanxi Provincial People's Hospital
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TaiyuanChinaUnknown status
Cardiovascular Hospital Affiliated to Shanxi Medical University
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TaiyuanChinaUnknown status
Tianjin Huanhu Hospital
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TianjinChinaUnknown status
The First People's Hospital of Tianmen in Hubei Province
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TianmenChinaUnknown status
Xihua People's Hospital
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Wacheng NeighborhoodChinaUnknown status
Wuhan University Renmin Hospital
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WuhanChinaUnknown status
The Third People's Hospital of Hubei Province
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WuhanChinaUnknown status
The First people's Hospital of Jiangxia District
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WuhanChinaUnknown status
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
Wuhan NO.1 Hospital
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WuhanChinaUnknown status
Zhongnan Hospital of Wuhan University
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WuhanChinaUnknown status
Wuhan Hankou Hospital
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WuhanChinaUnknown status
Yijishan Hospital of Wannan Medical College
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WuhuChinaUnknown status
The First Affiliated hospital of Xiamen University
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XiamenChinaUnknown status
Zhongshan Hosipital Xiamen University
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XiamenChinaUnknown status
Xiangyang Hospital of Traditional Chinese Medicine
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XiangyangChinaUnknown status
Xiangyang No.1 People's Hospital, Hubei University of Medicine.
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XiangyangChinaUnknown status
Xianning Central Hospital
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XianningChinaUnknown status
The First People's Hospital of Xianyang
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XianyangChinaUnknown status
The affiliated hospital of xuzhou medical university
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XuzhouChinaUnknown status
The Second People's Hospital of Yichang
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YichangChinaUnknown status
Yingtan People's Hospital
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YingtanChinaUnknown status
Red Cross Hospital of Yulin City
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YulinChinaUnknown status
909th Hospital of PLA Joint Logistic Support Force
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ZhangzhouChinaUnknown status
Zhangzhou Municipal Hospital of Fujian Province
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ZhangzhouChinaUnknown status
Affiliated Hospital of Guangdong Medical University
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ZhanjiangChinaUnknown status
Central people' s hospital of zhanjiang
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ZhanjiangChinaUnknown status
Zhoukou Centeral Hospital
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ZhoukouChinaUnknown status
ZhuMaDian Centeral Hospital
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ZhumadianChinaUnknown status
Zhumadian First People's Hospital
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ZhumadianChinaUnknown status
Zigong Third People's Hospital
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ZigongChinaUnknown status
Zoucheng People's Hospital, Shandong Province
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ZouchengChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.