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Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Compound Edaravone Injection
Edaravone Injection
Sponsored by
Jiangsu Simcere Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Compound Edaravone

Edaravone

Arm Description

Compound Edaravone Injection 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days

Edaravone Injection 30 mg/dose, one dose every 12 hours, continues for 14 days

Outcomes

Primary Outcome Measures

The proportion of patients with mRS ≤1 on day 90

Secondary Outcome Measures

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

Full Information

First Posted
April 20, 2015
Last Updated
January 12, 2017
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02430350
Brief Title
Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke
Official Title
Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Parallel, and Active-controlled PhaseⅢTrial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compound Edaravone
Arm Type
Experimental
Arm Description
Compound Edaravone Injection 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days
Arm Title
Edaravone
Arm Type
Active Comparator
Arm Description
Edaravone Injection 30 mg/dose, one dose every 12 hours, continues for 14 days
Intervention Type
Drug
Intervention Name(s)
Compound Edaravone Injection
Intervention Type
Drug
Intervention Name(s)
Edaravone Injection
Primary Outcome Measure Information:
Title
The proportion of patients with mRS ≤1 on day 90
Time Frame
day 90
Secondary Outcome Measure Information:
Title
mRS score on day 90
Time Frame
day 90
Title
Changes of NIHSS score from baseline on day 14
Time Frame
day 14
Title
The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90
Time Frame
day 14, 30, 90
Title
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
Title
Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90
Time Frame
day 14, 30, 90
Title
Stroke Impact Scale (SIS) score on day 90
Time Frame
day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongjun Wang, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Navy General Hospital of The Chinese PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100048
Country
China
Facility Name
Beijing Tian Tan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
The First Affiliated Hospital of Jinan University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China
Facility Name
Affiliated Hospital of Guilin Medical University
City
Guilin
State/Province
Guangxi
ZIP/Postal Code
541001
Country
China
Facility Name
Liuzhou Worker's Hospital
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545005
Country
China
Facility Name
Nanning Second People's Hospital
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530031
Country
China
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550004
Country
China
Facility Name
Cangzhou Central Hospital
City
Cangzhou
State/Province
Hebei
ZIP/Postal Code
061000
Country
China
Facility Name
The Second Affiliated Hospital of Haerbin Medical University
City
Haerbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Hunan Provincial People's Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Facility Name
The First Affiliated Hospital of University of South China
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421001
Country
China
Facility Name
The First Affiliated Hospital of Baotou Medical College
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014010
Country
China
Facility Name
The Third Affiliated Hospital of Inner Mongolia Medical University
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014010
Country
China
Facility Name
Central Hospital of Baotou
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014040
Country
China
Facility Name
Inner Mongolia Autonomous Region People's Hospital
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010017
Country
China
Facility Name
Affiliated Hospital of Inner Mongolia Medical University
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010050
Country
China
Facility Name
Huai'an First Affiliated Hospital of Nanjing Medical University
City
Huai'an
State/Province
Jiangsu
ZIP/Postal Code
223300
Country
China
Facility Name
Lianyungang First People's Hospital
City
Lianyungang
State/Province
Jiangsu
ZIP/Postal Code
222002
Country
China
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Facility Name
Zhongda Hospital,Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Facility Name
Nanjing Brain Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical College
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221006
Country
China
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Facility Name
Yangzhou No.1 People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Facility Name
The Forth Hospital of Jilin University
City
Siping
State/Province
Jilin
ZIP/Postal Code
130011
Country
China
Facility Name
Siping Central Hospital
City
Siping
State/Province
Jilin
ZIP/Postal Code
136000
Country
China
Facility Name
The General Hospital of Shenyang Military, Chinese PLA
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Facility Name
The Sceond Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250033
Country
China
Facility Name
Liaocheng People's Hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
252000
Country
China
Facility Name
Qingdao Municipal Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266011
Country
China
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Name
Yangpu Hospital, Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200090
Country
China
Facility Name
The Second Affiliated Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin People's Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Tianjin Huanhu Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
The Second Hospital of Tianjin Medical University
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300211
Country
China
Facility Name
Lishui People's Hospital
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323000
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33588596
Citation
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.
Results Reference
derived

Learn more about this trial

Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

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