Compound Edaravone Injection for Acute Ischemic Stroke
- Conditions
- Acute Ischemic Stroke
- Interventions
- Registration Number
- NCT01929096
- Lead Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Brief Summary
1. To investigate the efficacy and safety of multi-doses Compound Edaravone Injection versus Edaravone Injection for acute ischemic stroke patients;
2. To provide evidence for the design of Compound Edaravone Injection Phase III trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- 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 to 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;
- Creatinine clearance is less than 30 ml/min or previously known severe renal diseases;
- Therapeutic neuroprotective agents have been applied after onset, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
- Arterial or venous thrombolytic therapy has been applied after onset;
- With malignant tumors or receiving concurrent antitumor treatment;
- With severe systemic disease, life expectancy is less than 90 days;
- Pregnant or lactating women;
- Participate in other clinical studies within 30 days before randomization;
- The investigators consider the patients are not suitable for this trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Edaravone Injection Edaravone Injection，30 mg/dose, one dose every 12 hours, continues for 14 days Low-dose group Compound Edaravone Injection Compound Edaravone Injection, 12.5mg/dose (Edaravone 10mg, (+)-Borneol 2.5mg), one dose every 12 hours, continue for 14 days Medium-dose group Compound Edaravone Injection Compound Edaravone Injection, 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days High-dose group Compound Edaravone Injection Compound Edaravone Injection, 62.5mg/dose (Edaravone 50mg, (+)-Borneol 12.5mg), one dose every 12 hours, continue for 14 days
- Primary Outcome Measures
Name Time Method Change from baseline NIHSS score on day 14 day 14 mRS score on day 90 day 90
- Secondary Outcome Measures
Name Time Method The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90 day 14, 30, 90 The Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90 day 14, 30, 90 Stroke Impact Scale (SIS) score on day 90 day 90 The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90 day 14, 30, 90
Trial Locations
- Locations (28)
Central Hospital of Baotou
🇨🇳Baotou, Inner Mongolia, China
The Affiliated Hospital of Xuzhou Medical College
🇨🇳Xuzhou, Jiangsu, China
Navy General Hospital of The Chinese PLA
🇨🇳Beijing, Beijing, China
The General Hospital of Shenyang Military, Chinese PLA
🇨🇳Shenyang, Liaoning, China
Beijing Tiantan Hospital affiliated to Capital Medical University
🇨🇳Beijing, Beijing, China
Nanjing Brain Hospital
🇨🇳Nanjing, Jiangsu, China
Qingdao Municipal Hospital
🇨🇳Qingdao, Shandong, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Third Military Medical University of Chinese PLA
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Haerbin Medical University
🇨🇳Haerbin, Heilongjiang, China
Hunan Provincial People's Hospital
🇨🇳Changsha, Hunan, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Shanghai Changzheng Hospital
🇨🇳Shanghai, Shanghai, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Jiangxi Provincial People's Hospital
🇨🇳Nanchang, Jiangxi, China
The Second Hospital of Shandong University
🇨🇳Jinan, Shandong, China
The First Affiliated Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
The Second Affiliated Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin People's Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Huanhu Hospital
🇨🇳Tianjin, Tianjin, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Hebei General Hospital
🇨🇳Shijiazhuang, Hebei, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China