Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: Compound Edaravone Injection; Drug: Edaravone Injection

• Study Type: Interventional
• Enrollment (Actual): 1200
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients with mRS ≤1 on day 90	day 90

Secondary Outcome Measures

Outcome Measure	Time Frame
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
The proportion of patients with Barthel Index (BI) score greater than or equal to 95 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
Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90	day 14, 30, 90

Collaborators and Investigators

• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Yongjun Wang, MD, Beijing Tiantan Hospital

Publications and helpful links

General Publications

• Xu J, Wang A, Meng X, Yalkun G, Xu A, Gao Z, Chen H, Ji Y, Xu J, Geng D, Zhu R, Liu B, Dong A, Mu H, Lu Z, Li S, Zheng H, Chen X, Wang Y, Zhao X, Wang Y; TASTE Trial Investigatorsdagger. Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial. Stroke. 2021 Mar;52(3):772-780. doi: 10.1161/STROKEAHA.120.031197. Epub 2021 Feb 16.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 20, 2015
• First Submitted That Met QC Criteria: April 26, 2015
• First Posted (Estimate): April 30, 2015

Study Record Updates

• Last Update Posted (Estimate): January 16, 2017
• Last Update Submitted That Met QC Criteria: January 12, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neuroprotective Agents; Protective Agents; Antioxidants; Free Radical Scavengers; Edaravone
• Other Study ID Numbers: SIM-23-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided