Methylprednisolone Adjunctive to Endovascular Thrombectomy for Stroke
MIRACLE
Methylprednisolone as Adjunct to Endovascular Thrombectomy for Patients With Acute Ischemic Strokes With Large Infarct: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial (MIRACLE)
1 other identifier
interventional
928
1 country
99
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2024
Longer than P75 for phase_3
99 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2024
CompletedFirst Posted
Study publicly available on registry
April 11, 2024
CompletedStudy Start
First participant enrolled
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2030
ExpectedDecember 3, 2025
November 1, 2025
1.2 years
April 7, 2024
November 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
All-cause mortality at 90 (±14) days
Primary Efficacy Outcome. Defined as the number of any cause deaths observed divided by the number of subjects observed over the 90-day study period.
From randomization to 90 (±14) days
Secondary Outcomes (19)
Time from randomization to the occurrence of death from any cause at 90 (±14) days
From randomization to 90 (±14) days
mRS ordinal shift at 90 (±14) days (scores 5 and 6 are merged)
From randomization to 90 (±14) days
Proportion of patients with mRS score 0 to 4 at 90 (±14) days
From randomization to 90 (±14) days
Proportion of patients with mRS score 0 to 3 at 90 (±14) days
From randomization to 90 (±14) days
Proportion of patients with mRS score 0 to 2 at 90 (±14) days
From randomization to 90 (±14) days
- +14 more secondary outcomes
Other Outcomes (8)
mRS ordinal shift at 1 year (scores 5 and 6 are merged)
From randomization to 1 year
Proportion of patients with mRS score 0 to 2 at 1 year
From randomization to 1 year
Proportion of patients with mRS score 0 to 1 at 1 year or return to pre-stroke mRS score (for patients with pre-stroke mRS > 1)
From randomization to 1 year
- +5 more other outcomes
Study Arms (2)
Methylprednisolone sodium succinate group
EXPERIMENTALPlacebo group
PLACEBO COMPARATORMethylprednisolone sodium succinate simulant
Interventions
Intravenous injection of methylprednisolone sodium succinate (Chongqing Lummy Pharmaceutical Co., Ltd., 40mg/bottle) with a dose of 2mg/kg (maximum dose of 160mg), once daily, for three consecutive days. The initial study drug will be administered as soon as possible after randomization. It is recommended that the initial study drug administrated before arterial access closure, but it should not be delayed more than 2 hours after arterial access closure.
Intravenous injection of placebo (Chongqing Lummy Pharmaceutical Co., Ltd., 40mg/bottle) with a dose of 2mg/kg (maximum dose of 160mg), once daily, for three consecutive days. The initial study drug will be administered as soon as possible after randomization. It is recommended that the initial study drug administrated before arterial access closure, but it should not be delayed more than 2 hours after arterial access closure.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Intracranial hemorrhage confirmed by cranial CT or MRI.
- mRS score \> 2 before onset.
- Pregnant or lactating women.
- Allergic to contrast agents or glucocorticoids.
- Participating in other clinical trials.
- The artery is tortuous so that the thrombectomy device cannot reach the target vessel.
- Bleeding history (gastrointestinal and urinary tract bleeding) in recent 1 month.
- Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate \< 30 ml/min or serum creatinine \> 220 umol/L \[2.5 mg/ dL\]).
- Life expectancy due to any advanced disease \< 6 months.
- Follow-up is not expected to be completed.
- Intracranial aneurysm and arteriovenous malformation.
- Brain tumors with imaging mass effect.
- Systemic infectious disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wan-Jin Chenlead
Study Sites (99)
The First Affiliated Hospital of USTC
Hefei, Anhui, 230001, China
Hefei First People's Hospital
Hefei, Anhui, 230061, China
Taihe County People's Hospital
Taihe Chengguanzhen, Anhui, 236600, China
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, 241001, China
Anxi County Hospital
Anxi, Fujian, 362400, China
Anxi Hospital of Traditional Chinese Medicine
Anxi, Fujian, 362400, China
Fuqing City Hospital of Fujian
Fuqing, Fujian, 350300, China
Fuzhou University Affiliated Provincial Hospital
Fuzhou, Fujian, 350001, China
Union Hospital Affiliated to Fujian Medical University
Fuzhou, Fujian, 350001, China
The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine
Fuzhou, Fujian, 350003, China
Department of Neurology, First Affiliated Hospital Fujian Medical University
Fuzhou, Fujian, 350005, China
900th Hospital of PLA Joint Logistic Support Force
Fuzhou, Fujian, 350025, China
Longyan First Affiliated Hospital of Fujian Medical University
Longyan, Fujian, 364000, China
Nanping First Hospital
Nanping, Fujian, 353000, China
Mindong Hospital
Ningde, Fujian, 352100, China
Ningde Municipal Hospital, Ningde Normal University
Ningde, Fujian, 352100, China
Putian University Affiliated Hospital
Putian, Fujian, 351100, China
The First Hospital of Putian City
Putian, Fujian, 351100, China
Quanzhou First Hospital Affiliated to Fujian Medical University
Quanzhou, Fujian, 362000, China
The 910th Hospital of the Joint Logistics Support Force of the Chinese PLA
Quanzhou, Fujian, 362000, China
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000, China
Sanming First Hospital
Sanming, Fujian, 365000, China
Shaowu Municiple Hospital
Shaowu, Fujian, 354000, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Zhongshan Hosipital Xiamen University
Xiamen, Fujian, 361004, China
909th Hospital of PLA Joint Logistic Support Force
Zhangzhou, Fujian, 363000, China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, 363000, China
Gansu Province Central Hospital
Lanzhou, Gansu, 730050, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
Maoming Hospital of Traditional Chinese Medicine
Maoming, Guangdong, 525000, China
Maoming people's hospital
Maoming, Guangdong, 525000, China
Shantou Central Hospital
Shantou, Guangdong, 515031, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524001, China
Central people' s hospital of zhanjiang
Zhanjiang, Guangdong, 524037, China
Red Cross Hospital of Yulin City
Yulin, Guangxi, 537000, China
Guangzhou First People's Hospital
Guangzhou, Guangzhou, 510180, China
The First People's Hospital of Qingzhen
Qingzhen, Guizhou, 551400, China
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570311, China
Biyan People's Hospital
Bishui, Henan, 463700, China
Xihua People's Hospital
Wacheng Neighborhood, Henan, 466600, China
Zhoukou Centeral Hospital
Zhoukou, Henan, 466000, China
ZhuMaDian Centeral Hospital
Zhumadian, Henan, 463000, China
Zhumadian First People's Hospital
Zhumadian, Henan, 463000, China
The Central Hospital of Enshi Tujia And Miao Automomous Prefecture
Enshi, Hubei, 445000, China
Ezhou Central Hospital
Ezhou, Hubei, 436000, China
Qichun People's Hospital
Huanggang, Hubei, 435300, China
Huanggang Central Hospital
Huanggang, Hubei, 438000, China
Huangshi Central Hospital
Huangshi, Hubei, 435000, China
Yangtze University Affiliated Hospital
Jingzhou, Hubei, 434000, China
Jingzhou Hospital Affiliated to Yangtze University
Jingzhou, Hubei, 434020, China
Lichuan City Ethnic Traditional Chinese Medical Hospital
Lichuan, Hubei, 445400, China
Shiyan Hospital of Integrated Traditional and Western Medicine
Shiyan, Hubei, 442000, China
Shiyan Renmin Hospital
Shiyan, Hubei, 442000, China
Taihe Hospital Affiliated to Hubei University of Medicine
Shiyan, Hubei, 442000, China
The First People's Hospital of Tianmen in Hubei Province
Tianmen, Hubei, 431700, China
Wuhan Hankou Hospital
Wuhan, Hubei, 430012, China
The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430014, China
Wuhan NO.1 Hospital
Wuhan, Hubei, 430022, China
Tongji hospital, Tongji medical college, Huazhong university of science and technology
Wuhan, Hubei, 430030, China
The Third People's Hospital of Hubei Province
Wuhan, Hubei, 430033, China
Wuhan University Renmin Hospital
Wuhan, Hubei, 430060, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
The First people's Hospital of Jiangxia District
Wuhan, Hubei, 430200, China
Xiangyang Hospital of Traditional Chinese Medicine
Xiangyang, Hubei, 441000, China
Xiangyang No.1 People's Hospital, Hubei University of Medicine.
Xiangyang, Hubei, 441000, China
Xianning Central Hospital
Xianning, Hubei, 437100, China
The Second People's Hospital of Yichang
Yichang, Hubei, 443000, China
Baotou Central Hospital
Baotou, Inner Mongolia, 14040, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341000, China
Ganzhou People's Hospital, Ganzhou (G.Z.)
Ganzhou, Jiangxi, 341000, China
Jingdezhen First People's Hospital
Jingdezhen, Jiangxi, 333000, China
Jiujiang University Affiliated Hospital
Jiujiang, Jiangxi, 332000, China
The First People's Hospital of Jiujiang
Jiujiang, Jiangxi, 332000, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital, Jiangxi Medical College, Nanchang University
Nanchang, Jiangxi, 330006, China
Yingtan people's hospital
Yingtan, Jiangxi, 335000, China
The First People's Hospital of Xianyang
Xianyang, Shaanxi, 712000, China
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250011, China
Jinan Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250013, China
Liaocheng People's Hospital
Liaocheng, Shandong, 252000, China
Liaocheng third people's hospital
Liaocheng, Shandong, 252000, China
The Affiliated Hospital of Qingdao Univercity
Qingdao, Shandong, 266003, China
The Second Affiliated Hospital of Shandong First Medical University
Tai’an, Shandong, 271000, China
Zoucheng People's Hospital, Shandong Province
Zoucheng, Shandong, 273500, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Cardiovascular Hospital Affiliated to Shanxi Medical University
Taiyuan, Shanxi, 30001, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 30012, China
Chongzhou People's Hospital
Chengdu, Sichuan, 611230, China
Gulin County People's Hospital
Gulin, Sichuan, 646500, China
Mianyang 404 Hospital
Mianyang, Sichuan, 621000, China
Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China
Mianyang, Sichuan, 621000, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000, China
Suining Central Hospital
Suining, Sichuan, 629000, China
Zigong Third People's Hospital
Zigong, Sichuan, 643020, China
Tianjin Huanhu Hospital
Tianjin, Tian, 300350, China
Bozhou People's Hospital
Bole, Xinjiang, 833400, China
Qujing NO.1 Hospital
Qujing, Yunnan, 655000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Vice President of Fujian Medical University and Vice President of The First Affiliated Hospital of Fujian Medical University
Study Record Dates
First Submitted
April 7, 2024
First Posted
April 11, 2024
Study Start
August 1, 2024
Primary Completion
September 30, 2025
Study Completion (Estimated)
June 30, 2030
Last Updated
December 3, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share