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ACTIVE NOT RECRUITING
NCT06360458
PHASE3

Methylprednisolone Adjunctive to Endovascular Thrombectomy for Stroke

Sponsor: Wan-Jin Chen

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

928

Start Date

2024-08-01

Completion Date

2030-06-30

Last Updated

2025-12-03

Healthy Volunteers

No

Interventions

DRUG

Methylprednisolone sodium succinate

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.

DRUG

Placebo

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.

Locations (99)

The First Affiliated Hospital of USTC

Hefei, Anhui, China

Hefei First People's Hospital

Hefei, Anhui, China

Taihe County People's Hospital

Taihe Chengguanzhen, Anhui, China

Yijishan Hospital of Wannan Medical College

Wuhu, Anhui, China

Anxi County Hospital

Anxi, Fujian, China

Anxi Hospital of Traditional Chinese Medicine

Anxi, Fujian, China

Fuqing City Hospital of Fujian

Fuqing, Fujian, China

Fuzhou University Affiliated Provincial Hospital

Fuzhou, Fujian, China

Union Hospital Affiliated to Fujian Medical University

Fuzhou, Fujian, China

The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine

Fuzhou, Fujian, China

Department of Neurology, First Affiliated Hospital Fujian Medical University

Fuzhou, Fujian, China

900th Hospital of PLA Joint Logistic Support Force

Fuzhou, Fujian, China

Longyan First Affiliated Hospital of Fujian Medical University

Longyan, Fujian, China

Nanping First Hospital

Nanping, Fujian, China

Mindong Hospital

Ningde, Fujian, China

Ningde Municipal Hospital, Ningde Normal University

Ningde, Fujian, China

Putian University Affiliated Hospital

Putian, Fujian, China

The First Hospital of Putian City

Putian, Fujian, China

Quanzhou First Hospital Affiliated to Fujian Medical University

Quanzhou, Fujian, China

The 910th Hospital of the Joint Logistics Support Force of the Chinese PLA

Quanzhou, Fujian, China

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, China

Sanming First Hospital

Sanming, Fujian, China

Shaowu Municiple Hospital

Shaowu, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Zhongshan Hosipital Xiamen University

Xiamen, Fujian, China

909th Hospital of PLA Joint Logistic Support Force

Zhangzhou, Fujian, China

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, China

Gansu Province Central Hospital

Lanzhou, Gansu, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Maoming Hospital of Traditional Chinese Medicine

Maoming, Guangdong, China

Maoming people's hospital

Maoming, Guangdong, China

Shantou Central Hospital

Shantou, Guangdong, China

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

Central people' s hospital of zhanjiang

Zhanjiang, Guangdong, China

Red Cross Hospital of Yulin City

Yulin, Guangxi, China

Guangzhou First People's Hospital

Guangzhou, Guangzhou, China

The First People's Hospital of Qingzhen

Qingzhen, Guizhou, China

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Biyan People's Hospital

Bishui, Henan, China

Xihua People's Hospital

Wacheng Neighborhood, Henan, China

Zhoukou Centeral Hospital

Zhoukou, Henan, China

ZhuMaDian Centeral Hospital

Zhumadian, Henan, China

Zhumadian First People's Hospital

Zhumadian, Henan, China

The Central Hospital of Enshi Tujia And Miao Automomous Prefecture

Enshi, Hubei, China

Ezhou Central Hospital

Ezhou, Hubei, China

Qichun People's Hospital

Huanggang, Hubei, China

Huanggang Central Hospital

Huanggang, Hubei, China

Huangshi Central Hospital

Huangshi, Hubei, China

Yangtze University Affiliated Hospital

Jingzhou, Hubei, China

Jingzhou Hospital Affiliated to Yangtze University

Jingzhou, Hubei, China

Lichuan City Ethnic Traditional Chinese Medical Hospital

Lichuan, Hubei, China

Shiyan Hospital of Integrated Traditional and Western Medicine

Shiyan, Hubei, China

Shiyan Renmin Hospital

Shiyan, Hubei, China

Taihe Hospital Affiliated to Hubei University of Medicine

Shiyan, Hubei, China

The First People's Hospital of Tianmen in Hubei Province

Tianmen, Hubei, China

Wuhan Hankou Hospital

Wuhan, Hubei, China

The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Wuhan NO.1 Hospital

Wuhan, Hubei, China

Tongji hospital, Tongji medical college, Huazhong university of science and technology

Wuhan, Hubei, China

The Third People's Hospital of Hubei Province

Wuhan, Hubei, China

Wuhan University Renmin Hospital

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

The First people's Hospital of Jiangxia District

Wuhan, Hubei, China

Xiangyang Hospital of Traditional Chinese Medicine

Xiangyang, Hubei, China

Xiangyang No.1 People's Hospital, Hubei University of Medicine.

Xiangyang, Hubei, China

Xianning Central Hospital

Xianning, Hubei, China

The Second People's Hospital of Yichang

Yichang, Hubei, China

Baotou Central Hospital

Baotou, Inner Mongolia, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China

Ganzhou People's Hospital, Ganzhou (G.Z.)

Ganzhou, Jiangxi, China

Jingdezhen First People's Hospital

Jingdezhen, Jiangxi, China

Jiujiang University Affiliated Hospital

Jiujiang, Jiangxi, China

The First People's Hospital of Jiujiang

Jiujiang, Jiangxi, China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

The First Affiliated Hospital, Jiangxi Medical College, Nanchang University

Nanchang, Jiangxi, China

Yingtan people's hospital

Yingtan, Jiangxi, China

The First People's Hospital of Xianyang

Xianyang, Shaanxi, China

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, China

Jinan Central Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

Liaocheng third people's hospital

Liaocheng, Shandong, China

The Affiliated Hospital of Qingdao Univercity

Qingdao, Shandong, China

The Second Affiliated Hospital of Shandong First Medical University

Tai’an, Shandong, China

Zoucheng People's Hospital, Shandong Province

Zoucheng, Shandong, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Cardiovascular Hospital Affiliated to Shanxi Medical University

Taiyuan, Shanxi, China

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Chongzhou People's Hospital

Chengdu, Sichuan, China

Gulin County People's Hospital

Gulin, Sichuan, China

Mianyang 404 Hospital

Mianyang, Sichuan, China

Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China

Mianyang, Sichuan, China

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

Suining Central Hospital

Suining, Sichuan, China

Zigong Third People's Hospital

Zigong, Sichuan, China

Tianjin Huanhu Hospital

Tianjin, Tian, China

Bozhou People's Hospital

Bole, Xinjiang, China

Qujing NO.1 Hospital

Qujing, Yunnan, China