Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke - Full Text View

Purpose

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.

Condition	Intervention	Phase
Acute Ischemic Stroke	Drug: Compound Edaravone Injection Drug: Edaravone Injection	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Parallel, and Active-controlled PhaseⅢTrial

Resource links provided by NLM:

Drug Information available for: Edaravone

U.S. FDA Resources

Further study details as provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

The proportion of patients with mRS ≤1 on day 90 [ Time Frame: day 90 ]

Secondary Outcome Measures:

mRS score on day 90 [ Time Frame: day 90 ]
Changes of NIHSS score from baseline on day 14 [ Time Frame: day 14 ]
The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90 [ Time Frame: day 14, 30, 90 ]
The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90 [ Time Frame: day 14, 30, 90 ]
Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90 [ Time Frame: day 14, 30, 90 ]
Stroke Impact Scale (SIS) score on day 90 [ Time Frame: day 90 ]


Enrollment:	1200
Study Start Date:	May 2015
Study Completion Date:	December 2016
Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Compound Edaravone Compound Edaravone Injection 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days	Drug: Compound Edaravone Injection
Active Comparator: Edaravone Edaravone Injection 30 mg/dose, one dose every 12 hours, continues for 14 days	Drug: Edaravone Injection

Eligibility


Ages Eligible for Study:	35 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02430350

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Locations


China, Beijing
China-Japan Friendship Hospital
Beijing, Beijing, China, 100029
Navy General Hospital of The Chinese PLA
Beijing, Beijing, China, 100048
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing, China, 100050
China, Fujian
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
China, Guangdong
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China, 510630
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
China, Guangxi
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China, 541001
Liuzhou Worker's Hospital
Liuzhou, Guangxi, China, 545005
Nanning Second People's Hospital
Nanning, Guangxi, China, 530031
China, Guizhou
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550004
China, Hebei
Cangzhou Central Hospital
Cangzhou, Hebei, China, 061000
China, Heilongjiang
The Second Affiliated Hospital of Haerbin Medical University
Haerbin, Heilongjiang, China, 150001
China, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
China, Hunan
Hunan Provincial People's Hospital
Changsha, Hunan, China, 410005
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China, 421001
China, Inner Mongolia
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China, 014010
The Third Affiliated Hospital of Inner Mongolia Medical University
Baotou, Inner Mongolia, China, 014010
Central Hospital of Baotou
Baotou, Inner Mongolia, China, 014040
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, China, 010017
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China, 010050
China, Jiangsu
Huai'an First Affiliated Hospital of Nanjing Medical University
Huai'an, Jiangsu, China, 223300
Lianyungang First People's Hospital
Lianyungang, Jiangsu, China, 222002
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
Zhongda Hospital,Southeast University
Nanjing, Jiangsu, China, 210009
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210011
Nanjing Brain Hospital
Nanjing, Jiangsu, China, 210029
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China, 221006
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China, 225001
Yangzhou No.1 People's Hospital
Yangzhou, Jiangsu, China, 225001
China, Jilin
The Second Hospital of Jilin University
Changchun, Jilin, China, 130041
The Forth Hospital of Jilin University
Siping, Jilin, China, 130011
Siping Central Hospital
Siping, Jilin, China, 136000
China, Liaoning
The General Hospital of Shenyang Military, Chinese PLA
Shenyang, Liaoning, China, 110016
China, Shandong
The Sceond Hospital of Shandong University
Jinan, Shandong, China, 250033
Liaocheng People's Hospital
Liaocheng, Shandong, China, 252000
Qingdao Municipal Hospital
Qingdao, Shandong, China, 266011
China, Shanghai
Shanghai Changzheng Hospital
Shanghai, Shanghai, China, 200003
Yangpu Hospital, Tongji University
Shanghai, Shanghai, China, 200090
China, Shanxi
The Second Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
China, Tianjin
Tianjin People's Hospital
Tianjin, Tianjin, China, 300000
Tianjin Medical University General Hospital
Tianjin, Tianjin, China, 300052
Tianjin Huanhu Hospital
Tianjin, Tianjin, China, 300060
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin, China, 300211
China, Zhejiang
Lishui People's Hospital
Lishui, Zhejiang, China, 323000
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000

Sponsors and Collaborators

Jiangsu Simcere Pharmaceutical Co., Ltd.

Investigators


Principal Investigator:	Yongjun Wang, MD	Beijing Tiantan Hospital

More Information


Responsible Party:	Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT02430350 History of Changes
Other Study ID Numbers:	SIM-23-02
Study First Received:	April 20, 2015
Last Updated:	January 12, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Additional relevant MeSH terms:


Stroke Ischemia Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia Phenylmethylpyrazolone	Antipyrine Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents

ClinicalTrials.gov processed this record on July 14, 2017