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)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Contact
Study Contact
- Name: Wan-Jin Chen, MD
- Phone Number: 86-13860601359
- Email: wanjinchen75@fjmu.edu.cn
Study Contact Backup
- Name: Ying Fu, MD
- Phone Number: 86-13920263588
- Email: fuying1995@163.com
Study Locations
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Anhui
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Hefei, Anhui, China, 230001
- The First Affiliated hospital of USTC
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Hefei, Anhui, China, 230061
- Hefei First People's Hospital
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Taihe Chengguanzhen, Anhui, China, 236600
- Taihe County People's Hospital
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Wuhu, Anhui, China, 241001
- Yijishan Hospital of Wannan Medical College
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Fujian
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Anxi, Fujian, China, 362400
- Anxi County Hospital
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Anxi, Fujian, China, 362400
- Anxi Hospital of Traditional Chinese Medicine
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Fuqing, Fujian, China, 350300
- Fuqing City Hospital of Fujian
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Fuzhou, Fujian, China, 350001
- Union Hospital Affiliated to Fujian Medical University
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Fuzhou, Fujian, China, 350001
- Fuzhou University Affiliated Provincial Hospital
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Fuzhou, Fujian, China, 350003
- The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine
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Fuzhou, Fujian, China, 350005
- Department of Neurology, First Affiliated Hospital Fujian Medical University
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Fuzhou, Fujian, China, 350025
- 900th Hospital of PLA Joint Logistic Support Force
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Longyan, Fujian, China, 364000
- Longyan First Affiliated Hospital of Fujian Medical University
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Nanping, Fujian, China, 353000
- Nanping First Hospital
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Ningde, Fujian, China, 352100
- Ningde Municipal Hospital, Ningde Normal University
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Ningde, Fujian, China, 352100
- Mindong Hospital
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Putian, Fujian, China, 351100
- The First Hospital of Putian City
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Putian, Fujian, China, 351100
- Putian University Affiliated Hospital
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Quanzhou, Fujian, China, 362000
- The Second Affiliated Hospital of Fujian Medical University
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Quanzhou, Fujian, China, 362000
- Quanzhou First Hospital Affiliated to Fujian Medical University
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Quanzhou, Fujian, China, 362000
- The 910th Hospital of the Joint Logistics Support Force of the Chinese PLA
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Sanming, Fujian, China, 365000
- Sanming First Hospital
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Shaowu, Fujian, China, 354000
- Shaowu Municiple Hospital
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Xiamen, Fujian, China, 361003
- The first affiliated hospital of xiamen university
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Xiamen, Fujian, China, 361004
- Zhongshan Hosipital Xiamen University
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Zhangzhou, Fujian, China, 363000
- Zhangzhou Municipal Hospital of Fujian Province
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Zhangzhou, Fujian, China, 363000
- 909th Hospital of PLA Joint Logistic Support Force
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Gansu
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Lanzhou, Gansu, China, 730050
- Gansu Province Central Hospital
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Guangdong
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Guangzhou, Guangdong, China, 510120
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
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Maoming, Guangdong, China, 525000
- Maoming People's Hospital
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Maoming, Guangdong, China, 525000
- Maoming Hospital of Traditional Chinese Medicine
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Shantou, Guangdong, China, 515031
- Shantou Central Hospital
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Zhanjiang, Guangdong, China, 524001
- Affiliated Hospital Of Guangdong Medical University
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Zhanjiang, Guangdong, China, 524037
- Central people' s hospital of zhanjiang
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Guangxi
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Yulin, Guangxi, China, 537000
- Red Cross Hospital of Yulin City
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Guangzhou
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Guangzhou, Guangzhou, China, 510180
- Guangzhou First People's Hospital
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Guizhou
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Qingzhen, Guizhou, China, 551400
- The First People's Hospital of Qingzhen
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Hainan
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Haikou, Hainan, China, 570102
- The First Affiliated Hospital of Hainan Medical University
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Haikou, Hainan, China, 570311
- The Second Affiliated Hospital of Hainan Medical University
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Henan
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Bishui, Henan, China, 463700
- Biyan People's Hospital
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Wacheng Neighborhood, Henan, China, 466600
- Xihua People's Hospital
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Zhoukou, Henan, China, 466000
- Zhoukou Centeral Hospital
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Zhumadian, Henan, China, 463000
- ZhuMaDian Centeral Hospital
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Zhumadian, Henan, China, 463000
- Zhumadian First People's Hospital
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Hubei
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Enshi, Hubei, China, 445000
- The Central Hospital of Enshi Tujia And Miao Automomous Prefecture
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Ezhou, Hubei, China, 436000
- Ezhou Central Hospital
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Huanggang, Hubei, China, 435300
- Qichun People's Hospital
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Huanggang, Hubei, China, 438000
- Huanggang Central Hospital
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Huangshi, Hubei, China, 435000
- Huangshi Central Hospital
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Jingzhou, Hubei, China, 434000
- Yangtze University Affiliated Hospital
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Jingzhou, Hubei, China, 434020
- Jingzhou Hospital Affiliated to Yangtze University
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Lichuan, Hubei, China, 445400
- Lichuan City Ethnic Traditional Chinese Medical Hospital
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Shiyan, Hubei, China, 442000
- Shiyan Renmin Hospital
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Shiyan, Hubei, China, 442000
- Shiyan Hospital of Integrated Traditional and Western Medicine
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Shiyan, Hubei, China, 442000
- Taihe Hospital Affiliated to Hubei University of Medicine
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Tianmen, Hubei, China, 431700
- The First People's Hospital of Tianmen in Hubei Province
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Wuhan, Hubei, China, 430071
- Zhongnan Hospital of Wuhan University
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Wuhan, Hubei, China, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Wuhan, Hubei, China, 430022
- Wuhan No.1 Hospital
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Wuhan, Hubei, China, 430012
- Wuhan Hankou Hospital
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Wuhan, Hubei, China, 430014
- The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology
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Wuhan, Hubei, China, 430033
- The Third People's Hospital of Hubei Province
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Wuhan, Hubei, China, 430060
- Wuhan University Renmin Hospital
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Wuhan, Hubei, China, 430200
- The First people's Hospital of Jiangxia District
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Xiangyang, Hubei, China, 441000
- Xiangyang Hospital of Traditional Chinese Medicine
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Xiangyang, Hubei, China, 441000
- Xiangyang No.1 People's Hospital, Hubei University of Medicine.
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Xianning, Hubei, China, 437100
- Xianning Central Hospital
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Yichang, Hubei, China, 443000
- The Second People's Hospital of Yichang
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Inner Mongolia
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Baotou, Inner Mongolia, China, 14040
- Baotou Central Hospital
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Jiangsu
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Xuzhou, Jiangsu, China, 221002
- The Affiliated Hospital of Xuzhou Medical University
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Jiangxi
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Ganzhou, Jiangxi, China, 341000
- First Affiliated Hospital of Gannan Medical University
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Ganzhou, Jiangxi, China, 341000
- Ganzhou People's Hospital, Ganzhou (G.Z.)
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Jingdezhen, Jiangxi, China, 333000
- Jingdezhen First People's Hospital
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Jiujiang, Jiangxi, China, 332000
- Jiujiang University Affiliated Hospital
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Jiujiang, Jiangxi, China, 332000
- The First People's Hospital of Jiujiang
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Nanchang, Jiangxi, China, 330006
- Jiangxi Provincial People's Hospital
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Nanchang, Jiangxi, China, 330006
- The First Affiliated Hospital, Jiangxi Medical College, Nanchang University
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Yingtan, Jiangxi, China, 335000
- Yingtan People's Hospital
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Shaanxi
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Xianyang, Shaanxi, China, 712000
- The First People's Hospital of Xianyang
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Shandong
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Jinan, Shandong, China, 250011
- Affiliated Hospital of Shandong University of Traditional Chinese Medicine
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Jinan, Shandong, China, 250013
- Jinan Central Hospital Affiliated to Shandong First Medical University
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Liaocheng, Shandong, China, 252000
- Liaocheng People's Hospital
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Liaocheng, Shandong, China, 252000
- Liaocheng Third People's Hospital
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Qingdao, Shandong, China, 266003
- The Affiliated Hospital of Qingdao Univercity
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Tai’an, Shandong, China, 271000
- The Second Affiliated Hospital of Shandong First Medical University
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Zoucheng, Shandong, China, 273500
- Zoucheng People's Hospital, Shandong Province
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200025
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
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Shanxi
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Taiyuan, Shanxi, China, 30012
- Shanxi Provincial People's Hospital
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Taiyuan, Shanxi, China, 30001
- Cardiovascular Hospital Affiliated to Shanxi Medical University
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Sichuan
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Chengdu, Sichuan, China, 611230
- Chongzhou People's Hospital
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Gulin, Sichuan, China, 646500
- Gulin County People's Hospital
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Mianyang, Sichuan, China, 621000
- Mianyang 404 Hospital
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Mianyang, Sichuan, China, 621000
- Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China
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Nanchong, Sichuan, China, 637000
- Affiliated Hospital of North Sichuan Medical College
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Suining, Sichuan, China, 629000
- Suining Central Hospital
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Zigong, Sichuan, China, 643020
- Zigong Third People's Hospital
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Tian
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Tianjin, Tian, China, 300350
- Tianjin Huanhu Hospital
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Xinjiang
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Bole, Xinjiang, China, 833400
- Bozhou People's Hospital
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Yunnan
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Qujing, Yunnan, China, 655000
- Qujing NO.1 Hospital
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Methylprednisolone sodium succinate group
|
Intravenous injection of methylprednisolone sodium succinate (Chongqing Lai Mei 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 randomisation.
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.
|
|
Placebo Comparator: Placebo group
Methylprednisolone sodium succinate simulant
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All-cause mortality at 90 (±14) days
Time Frame: From randomization to 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 Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of any complications
Time Frame: From date of randomization until the date of discharge, an average of 1 week
|
Secondary Safety Outcome
|
From date of randomization until the date of discharge, an average of 1 week
|
|
Time from randomization to the occurrence of death from any cause at 90 (±14) days
Time Frame: From randomization to 90 (±14) days
|
Secondary Efficacy Outcome; To evaluate death rate of the two treatment groups
|
From randomization to 90 (±14) days
|
|
Proportion of patients with mRS score 0 to 4 at 90 (±14) days
Time Frame: From randomization to 90 (±14) days
|
Secondary Efficacy Outcome
|
From randomization to 90 (±14) days
|
|
Proportion of patients with mRS score 0 to 3 at 90 (±14) days
Time Frame: From randomization to 90 (±14) days
|
Secondary Efficacy Outcome
|
From randomization to 90 (±14) days
|
|
Proportion of patients with decompressive craniectomy after EVT
Time Frame: From randomization until the date of discharge, an average of 1 week
|
Secondary Efficacy Outcome
|
From randomization until the date of discharge, an average of 1 week
|
|
NIHSS score at 5-7 days or at early discharge
Time Frame: From randomization to 5-7 days ( or at early discharge)
|
Secondary Efficacy Outcome
|
From randomization to 5-7 days ( or at early discharge)
|
|
EQ-5D-5L VAS at 90 (±14) days
Time Frame: From randomization to 90 (±14) days
|
Secondary Efficacy Outcome
|
From randomization to 90 (±14) days
|
|
Proportion of patients with symptomatic intracranial haemorrhage (SICH) within 48 hours after EVT
Time Frame: From randomization to 48 hours
|
Primary Safety Outcome.
Based on the modified Heidelberg Bleeding Classification.
|
From randomization to 48 hours
|
|
Proportion of patients with any intracranial haemorrhage (ICH) within 48 hours after EVT
Time Frame: From randomization to 48 hours
|
Secondary Safety Outcome.
Based on the modified Heidelberg Bleeding Classification.
|
From randomization to 48 hours
|
|
Proportion of patients with pneumonia
Time Frame: From randomization until the date of discharge, an average of 1 week
|
Secondary Safety Outcome
|
From randomization until the date of discharge, an average of 1 week
|
|
Proportion of patients with gastrointestinal haemorrhage within 7 days after EVT
Time Frame: From randomization to 7 days
|
Secondary Safety Outcome
|
From randomization to 7 days
|
|
Incidence of any (serious) adverse events
Time Frame: From randomization to 90 (±14) days
|
Secondary Safety Outcome
|
From randomization to 90 (±14) days
|
|
Midline shift at 48 hours
Time Frame: From randomization to 48 hours
|
Secondary Efficacy Outcome
|
From randomization to 48 hours
|
|
Net water uptake at 48 hours
Time Frame: From randomization to 48 hours
|
Secondary Efficacy Outcome
|
From randomization to 48 hours
|
|
mRS ordinal shift at 90 (±14) days (scores 5 and 6 are merged)
Time Frame: From randomization to 90 (±14) days
|
Secondary Efficacy Outcome
|
From randomization to 90 (±14) days
|
|
Proportion of patients with mRS score 0 to 2 at 90 (±14) days
Time Frame: From randomization to 90 (±14) days
|
Secondary Efficacy Outcome
|
From randomization to 90 (±14) days
|
|
Proportion of patients with mRS score 0 to 1 at 90 (±14) days or return to pre-stroke mRS score (for patients with pre-stroke mRS > 1)
Time Frame: From randomization to 90 (±14) days
|
Secondary Efficacy Outcome
|
From randomization to 90 (±14) days
|
|
Proportion of patients with midline shift >5 mm within 48 hours after EVT
Time Frame: From randomization to 48 hours
|
Secondary Efficacy Outcome
|
From randomization to 48 hours
|
|
Relative hemispheric volume at 48 hours
Time Frame: From randomization to 48 hours
|
Secondary Efficacy Outcome.
|
From randomization to 48 hours
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EQ-5D-5L VAS at 1 year
Time Frame: From randomization to 1 year
|
Tertiary Efficacy Outcome
|
From randomization to 1 year
|
|
EQ-5D-5L VAS at 5 years
Time Frame: From randomization to 5 years
|
Tertiary Efficacy Outcome
|
From randomization to 5 years
|
|
mRS ordinal shift at 1 year (scores 5 and 6 are merged)
Time Frame: From randomization to 1 year
|
Tertiary Efficacy Outcome
|
From randomization to 1 year
|
|
Proportion of patients with mRS score 0 to 2 at 1 year
Time Frame: From randomization to 1 year
|
Tertiary Efficacy Outcome
|
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)
Time Frame: From randomization to 1 year
|
Tertiary Efficacy Outcome
|
From randomization to 1 year
|
|
mRS ordinal shift at 5 years (scores 5 and 6 are merged)
Time Frame: From randomization to 5 years
|
Tertiary Efficacy Outcome
|
From randomization to 5 years
|
|
Proportion of patients with mRS score 0 to 2 at 5 years
Time Frame: From randomization to 5 years
|
Tertiary Efficacy Outcome
|
From randomization to 5 years
|
|
Proportion of patients with mRS score 0 to 1 at 5 years or return to pre-stroke mRS score (for patients with pre-stroke mRS > 1)
Time Frame: From randomization to 5 years
|
Tertiary Efficacy Outcome
|
From randomization to 5 years
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Stroke
- Ischemic Stroke
- Polycyclic Compounds
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Pregnadienetriols
- Methylprednisolone
- Prednisolone
- Methylprednisolone Hemisuccinate
Other Study ID Numbers
Other Study ID Numbers
- MRCTA,ECFAH of FMU[2024]368-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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