Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Parallel, and Active-controlled PhaseⅢTrial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02430350
• Other study ID #: SIM-23-02
• Status: Completed
• Phase: Phase 3
• First received: April 20, 2015
• Last updated: January 12, 2017
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Stroke

Intervention

Drug:
• Compound Edaravone Injection

• Edaravone Injection

Locations

Country	Name	City	State
China	Central Hospital of Baotou	Baotou	Inner Mongolia
China	The First Affiliated Hospital of Baotou Medical College	Baotou	Inner Mongolia
China	The Third Affiliated Hospital of Inner Mongolia Medical University	Baotou	Inner Mongolia
China	Beijing Tian Tan Hospital, Capital Medical University	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Navy General Hospital of The Chinese PLA	Beijing	Beijing
China	Cangzhou Central Hospital	Cangzhou	Hebei
China	The Second Hospital of Jilin University	Changchun	Jilin
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong
China	Affiliated Hospital of Guilin Medical University	Guilin	Guangxi
China	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	The Second Affiliated Hospital of Haerbin Medical University	Haerbin	Heilongjiang
China	The First Affiliated Hospital of University of South China	Hengyang	Hunan
China	Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia
China	Inner Mongolia Autonomous Region People's Hospital	Hohhot	Inner Mongolia
China	Huai'an First Affiliated Hospital of Nanjing Medical University	Huai'an	Jiangsu
China	The Sceond Hospital of Shandong University	Jinan	Shandong
China	Lianyungang First People's Hospital	Lianyungang	Jiangsu
China	Liaocheng People's Hospital	Liaocheng	Shandong
China	Lishui People's Hospital	Lishui	Zhejiang
China	Liuzhou Worker's Hospital	Liuzhou	Guangxi
China	Nanjing Brain Hospital	Nanjing	Jiangsu
China	Nanjing First Hospital	Nanjing	Jiangsu
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Zhongda Hospital,Southeast University	Nanjing	Jiangsu
China	Nanning Second People's Hospital	Nanning	Guangxi
China	Qingdao Municipal Hospital	Qingdao	Shandong
China	Shanghai Changzheng Hospital	Shanghai	Shanghai
China	Yangpu Hospital, Tongji University	Shanghai	Shanghai
China	The General Hospital of Shenyang Military, Chinese PLA	Shenyang	Liaoning
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	Siping Central Hospital	Siping	Jilin
China	The Forth Hospital of Jilin University	Siping	Jilin
China	The Second Affiliated Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	The Second Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Tianjin Huanhu Hospital	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Tianjin People's Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	The Affiliated Hospital of Xuzhou Medical College	Xuzhou	Jiangsu
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu
China	Yangzhou No.1 People's Hospital	Yangzhou	Jiangsu
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with mRS =1 on day 90		day 90
Secondary	mRS score on day 90		day 90
Secondary	Changes of NIHSS score from baseline on day 14		day 14
Secondary	The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90		day 14, 30, 90
Secondary	The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90		day 14, 30, 90
Secondary	Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90		day 14, 30, 90
Secondary	Stroke Impact Scale (SIS) score on day 90		day 90