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
Sites (99)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anxi County Hospital Coordinator of this site? Confirm its status | Anxi | China | Unknown status |
| Anxi Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Anxi | China | Unknown status |
| Baotou Central Hospital Coordinator of this site? Confirm its status | Baotou | China | Unknown status |
| Biyan People's Hospital Coordinator of this site? Confirm its status | Biyang | China | Unknown status |
| Bozhou People's Hospital Coordinator of this site? Confirm its status | Bole | China | Unknown status |
| Chongzhou People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The Central Hospital of Enshi Tujia And Miao Automomous Prefecture Coordinator of this site? Confirm its status | Enshi | China | Unknown status |
| Ezhou Central Hospital Coordinator of this site? Confirm its status | Ezhou | China | Unknown status |
| Fuqing City Hospital of Fujian Coordinator of this site? Confirm its status | Fuqing | China | Unknown status |
| Fuzhou University Affiliated Provincial Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| 900th Hospital of PLA Joint Logistic Support Force Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Department of Neurology, First Affiliated Hospital Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Union Hospital Affiliated to Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| First Affiliated Hospital Of Gannan Medical University Coordinator of this site? Confirm its status | Ganzhou | China | Unknown status |
| Ganzhou People's Hospital, Ganzhou (G.Z.) Coordinator of this site? Confirm its status | Ganzhou | China | Unknown status |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangzhou First People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Gulin County People's Hospital Coordinator of this site? Confirm its status | Gulin | China | Unknown status |
| The Second Affiliated Hospital of Hainan Medical University Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| The First Affiliated Hospital of Hainan Medical University Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| The First Affiliated Hospital of USTC Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Hefei First People's Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Huanggang Central Hospital Coordinator of this site? Confirm its status | Huanggang | China | Unknown status |
| Qichun People's Hospital Coordinator of this site? Confirm its status | Huanggang | China | Unknown status |
| Huangshi Central Hospital Coordinator of this site? Confirm its status | Huangshi | China | Unknown status |
| Affiliated Hospital of Shandong University of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Jinan Central Hospital Affiliated to Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Jingdezhen First People's Hospital Coordinator of this site? Confirm its status | Jingdezhen | China | Unknown status |
| Yangtze University Affiliated Hospital Coordinator of this site? Confirm its status | Jingzhou | China | Unknown status |
| Jingzhou Hospital Affiliated to Yangtze University Coordinator of this site? Confirm its status | Jingzhou | China | Unknown status |
| Jiujiang University Affiliated Hospital Coordinator of this site? Confirm its status | Jiujiang | China | Unknown status |
| The First People's Hospital of Jiujiang Coordinator of this site? Confirm its status | Jiujiang | China | Unknown status |
| Gansu Province Central Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| Liaocheng People's Hospital Coordinator of this site? Confirm its status | Liaocheng | China | Unknown status |
| Liaocheng Third People's Hospital Coordinator of this site? Confirm its status | Liaocheng | China | Unknown status |
| Lichuan City Ethnic Traditional Chinese Medical Hospital Coordinator of this site? Confirm its status | Lichuan | China | Unknown status |
| Longyan First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Longyan | China | Unknown status |
| Maoming Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Maoming | China | Unknown status |
| Maoming people's hospital Coordinator of this site? Confirm its status | Maoming | China | Unknown status |
| Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China Coordinator of this site? Confirm its status | Mianyang | China | Unknown status |
| Mianyang 404 Hospital Coordinator of this site? Confirm its status | Mianyang | China | Unknown status |
| Jiangxi Provincial People's Hospital Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| The First Affiliated Hospital, Jiangxi Medical College, Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Affiliated Hospital of North Sichuan Medical College Coordinator of this site? Confirm its status | Nanchong | China | Unknown status |
| Nanping First Hospital Coordinator of this site? Confirm its status | Nanping | China | Unknown status |
| Ningde Municipal Hospital, Ningde Normal University Coordinator of this site? Confirm its status | Ningde | China | Unknown status |
| Mindong Hospital Coordinator of this site? Confirm its status | Ningde | China | Unknown status |
| Putian University Affiliated Hospital Coordinator of this site? Confirm its status | Putian | China | Unknown status |
| The First Hospital of Putian City Coordinator of this site? Confirm its status | Putian | China | Unknown status |
| The Affiliated Hospital of Qingdao Univercity Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| The First People's Hospital of Qingzhen Coordinator of this site? Confirm its status | Qingzhen | China | Unknown status |
| The Second Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Quanzhou | China | Unknown status |
| The 910th Hospital of the Joint Logistics Support Force of the Chinese PLA Coordinator of this site? Confirm its status | Quanzhou | China | Unknown status |
| Quanzhou First Hospital Affiliated to Fujian Medical University Coordinator of this site? Confirm its status | Quanzhou | China | Unknown status |
| Qujing NO.1 Hospital Coordinator of this site? Confirm its status | Qujing | China | Unknown status |
| SanMing First Hospital Coordinator of this site? Confirm its status | Sanming | China | Unknown status |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shantou Central Hospital Coordinator of this site? Confirm its status | Shantou | China | Unknown status |
| Shaowu Municiple Hospital Coordinator of this site? Confirm its status | Shaowu | China | Unknown status |
| Taihe Hospital Affiliated to Hubei University of Medicine Coordinator of this site? Confirm its status | Shiyan | China | Unknown status |
| Shiyan Hospital of Integrated Traditional and Western Medicine Coordinator of this site? Confirm its status | Shiyan | China | Unknown status |
| Shiyan Renmin Hospital Coordinator of this site? Confirm its status | Shiyan | China | Unknown status |
| Suining Central Hospital Coordinator of this site? Confirm its status | Suining | China | Unknown status |
| The Second Affiliated Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Tai’an | China | Unknown status |
| Taihe County People's Hospital Coordinator of this site? Confirm its status | Taihe Chengguanzhen | China | Unknown status |
| Shanxi Provincial People's Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Cardiovascular Hospital Affiliated to Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Tianjin Huanhu Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The First People's Hospital of Tianmen in Hubei Province Coordinator of this site? Confirm its status | Tianmen | China | Unknown status |
| Xihua People's Hospital Coordinator of this site? Confirm its status | Wacheng Neighborhood | China | Unknown status |
| Wuhan University Renmin Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The Third People's Hospital of Hubei Province Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The First people's Hospital of Jiangxia District Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Wuhan NO.1 Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Zhongnan Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Wuhan Hankou Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Yijishan Hospital of Wannan Medical College Coordinator of this site? Confirm its status | Wuhu | China | Unknown status |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| Zhongshan Hosipital Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| Xiangyang Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Xiangyang | China | Unknown status |
| Xiangyang No.1 People's Hospital, Hubei University of Medicine. Coordinator of this site? Confirm its status | Xiangyang | China | Unknown status |
| Xianning Central Hospital Coordinator of this site? Confirm its status | Xianning | China | Unknown status |
| The First People's Hospital of Xianyang Coordinator of this site? Confirm its status | Xianyang | China | Unknown status |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| The Second People's Hospital of Yichang Coordinator of this site? Confirm its status | Yichang | China | Unknown status |
| Yingtan People's Hospital Coordinator of this site? Confirm its status | Yingtan | China | Unknown status |
| Red Cross Hospital of Yulin City Coordinator of this site? Confirm its status | Yulin | China | Unknown status |
| 909th Hospital of PLA Joint Logistic Support Force Coordinator of this site? Confirm its status | Zhangzhou | China | Unknown status |
| Zhangzhou Municipal Hospital of Fujian Province Coordinator of this site? Confirm its status | Zhangzhou | China | Unknown status |
| Affiliated Hospital of Guangdong Medical University Coordinator of this site? Confirm its status | Zhanjiang | China | Unknown status |
| Central people' s hospital of zhanjiang Coordinator of this site? Confirm its status | Zhanjiang | China | Unknown status |
| Zhoukou Centeral Hospital Coordinator of this site? Confirm its status | Zhoukou | China | Unknown status |
| ZhuMaDian Centeral Hospital Coordinator of this site? Confirm its status | Zhumadian | China | Unknown status |
| Zhumadian First People's Hospital Coordinator of this site? Confirm its status | Zhumadian | China | Unknown status |
| Zigong Third People's Hospital Coordinator of this site? Confirm its status | Zigong | China | Unknown status |
| Zoucheng People's Hospital, Shandong Province Coordinator of this site? Confirm its status | Zoucheng | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.