Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke
- Conditions
- Acute Ischemic Stroke
- Interventions
- Registration Number
- NCT02430350
- Lead Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Brief Summary
The primary objective of the study is to confirm the efficacy of compound Edaravone Injection via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a double-blind, active-controlled manner. The study is also to examine the safety of compound Edaravone Injection for the AIS patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1200
- Hospitalized patients, diagnosed of ischemic stroke;
- Onset of stroke is less than or equal to 48 hours;
- There are clear signs of neurological deficit: 4≤NIHSS score≤24, and also, the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2;
- Patients signed written inform consent
- Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage;
- Iatrogenic stroke;
- Severe disturbance of consciousness: NIHSS category 1a for consciousness is greater than 1；
- The mRS score prior to this onset is greater than 1;
- Transient ischemic attack (TIA);
- SBP after blood pressure control is still greater than or equal to 220 mmHg, or DBP after blood pressure control is still greater than or equal to 120 mmHg;
- Patients with severe mental disorders and dementia;
- ALT or AST is greater than 2.0×ULN or previously known liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis;
- Serum Creatinine (SCr) is greater than 1.5×ULN, Creatinine Clearance (CrCl) is less than 50 ml/min or previously known severe renal diseases;
- Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
- Arterial or venous thrombolytic therapy has been applied after onset of stroke;
- Patients with malignant tumors or receiving concurrent antitumor treatment;
- Patients with severe systemic disease, life expectancy is less than 90 days;
- allergic to edaravone , (+)-Borneol or related excipients;
- Pregnant or lactating women;
- Have major surgery within 4 weeks before enrollment;
- Participated in other clinical studies within 30 days before randomization; or participating in other clinical trials at present;
- The investigators consider the patients are not suitable for this trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Compound Edaravone Compound Edaravone Injection Compound Edaravone Injection 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days Edaravone Edaravone Injection Edaravone Injection 30 mg/dose, one dose every 12 hours, continues for 14 days
- Primary Outcome Measures
Name Time Method The proportion of patients with mRS ≤1 on day 90 day 90
- Secondary Outcome Measures
Name Time Method The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90 day 14, 30, 90 Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90 day 14, 30, 90 Stroke Impact Scale (SIS) score on day 90 day 90 Changes of NIHSS score from baseline on day 14 day 14 mRS score on day 90 day 90 The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90 day 14, 30, 90
Trial Locations
- Locations (48)
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Beijing Tian Tan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
Affiliated Hospital of Guilin Medical University
🇨🇳Guilin, Guangxi, China
Nanning Second People's Hospital
🇨🇳Nanning, Guangxi, China
Liuzhou Worker's Hospital
🇨🇳Liuzhou, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Cangzhou Central Hospital
🇨🇳Cangzhou, Hebei, China
The Second Affiliated Hospital of Haerbin Medical University
🇨🇳Haerbin, Heilongjiang, China
Hunan Provincial People's Hospital
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Baotou Medical College
🇨🇳Baotou, Inner Mongolia, China
The First Affiliated Hospital of University of South China
🇨🇳Hengyang, Hunan, China
Central Hospital of Baotou
🇨🇳Baotou, Inner Mongolia, China
Inner Mongolia Autonomous Region People's Hospital
🇨🇳Hohhot, Inner Mongolia, China
The Third Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Baotou, Inner Mongolia, China
Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
Huai'an First Affiliated Hospital of Nanjing Medical University
🇨🇳Huai'an, Jiangsu, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
Lianyungang First People's Hospital
🇨🇳Lianyungang, Jiangsu, China
Zhongda Hospital,Southeast University
🇨🇳Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical College
🇨🇳Xuzhou, Jiangsu, China
Yangzhou No.1 People's Hospital
🇨🇳Yangzhou, Jiangsu, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The Forth Hospital of Jilin University
🇨🇳Siping, Jilin, China
The General Hospital of Shenyang Military, Chinese PLA
🇨🇳Shenyang, Liaoning, China
Qingdao Municipal Hospital
🇨🇳Qingdao, Shandong, China
Shanghai Changzheng Hospital
🇨🇳Shanghai, Shanghai, China
Yangpu Hospital, Tongji University
🇨🇳Shanghai, Shanghai, China
The Second Affiliated Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Huanhu Hospital
🇨🇳Tianjin, Tianjin, China
Lishui People's Hospital
🇨🇳Lishui, Zhejiang, China
The Second Hospital of Tianjin Medical University
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
The First Affiliated Hospital of Jinan University
🇨🇳Guangzhou, Guangdong, China
Navy General Hospital of The Chinese PLA
🇨🇳Beijing, Beijing, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Nanjing Brain Hospital
🇨🇳Nanjing, Jiangsu, China
Northern Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
Siping Central Hospital
🇨🇳Siping, Jilin, China
The Sceond Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Liaocheng People's Hospital
🇨🇳Liaocheng, Shandong, China
Tianjin People's Hospital
🇨🇳Tianjin, Tianjin, China