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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone sodium succinate group | Experimental | ||
| Placebo group | Placebo Comparator | Methylprednisolone sodium succinate simulant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone sodium succinate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time from randomization to the occurrence of death from any cause at 90 (±14) days | Secondary Efficacy Outcome; To evaluate death rate of the two treatment groups | From randomization to 90 (±14) days |
| mRS ordinal shift at 90 (±14) days (scores 5 and 6 are merged) |
| Measure | Description | Time Frame |
|---|---|---|
| mRS ordinal shift at 1 year (scores 5 and 6 are merged) | Tertiary Efficacy Outcome | From randomization to 1 year |
| Proportion of patients with mRS score 0 to 2 at 1 year | Tertiary Efficacy Outcome |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC | Hefei | Anhui | 230001 | China | ||
| Hefei First People's Hospital |
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| Placebo | Drug | 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. |
|
Secondary Efficacy Outcome |
| From randomization to 90 (±14) days |
| Proportion of patients with mRS score 0 to 4 at 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 | Secondary Efficacy Outcome | From randomization to 90 (±14) days |
| Proportion of patients with mRS score 0 to 2 at 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) | Secondary Efficacy Outcome | From randomization to 90 (±14) days |
| Midline shift at 48 hours | Secondary Efficacy Outcome | From randomization to 48 hours |
| Proportion of patients with midline shift >5 mm within 48 hours after EVT | Secondary Efficacy Outcome | From randomization to 48 hours |
| Relative hemispheric volume at 48 hours | Secondary Efficacy Outcome. | From randomization to 48 hours |
| Net water uptake at 48 hours | Secondary Efficacy Outcome | From randomization to 48 hours |
| Proportion of patients with decompressive craniectomy after EVT | 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 | Secondary Efficacy Outcome | From randomization to 5-7 days ( or at early discharge) |
| EQ-5D-5L VAS at 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 | 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 | Secondary Safety Outcome. Based on the modified Heidelberg Bleeding Classification. | From randomization to 48 hours |
| Proportion of patients with pneumonia | 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 | Secondary Safety Outcome | From randomization to 7 days |
| Incidence of any complications | Secondary Safety Outcome | From date of randomization until the date of discharge, an average of 1 week |
| Incidence of any (serious) adverse events | Secondary Safety Outcome | From randomization to 90 (±14) days |
| 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) | Tertiary Efficacy Outcome | From randomization to 1 year |
| mRS ordinal shift at 5 years (scores 5 and 6 are merged) | Tertiary Efficacy Outcome | From randomization to 5 years |
| Proportion of patients with mRS score 0 to 2 at 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) | Tertiary Efficacy Outcome | From randomization to 5 years |
| EQ-5D-5L VAS at 1 year | Tertiary Efficacy Outcome | From randomization to 1 year |
| EQ-5D-5L VAS at 5 years | Tertiary Efficacy Outcome | From randomization to 5 years |
| 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 | Biyang | 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 |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008776 | Methylprednisolone Hemisuccinate |
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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