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
1 other identifier
interventional
1,200
1 country
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2015
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2015
CompletedFirst Posted
Study publicly available on registry
April 30, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 16, 2017
January 1, 2017
1.6 years
April 20, 2015
January 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of patients with mRS ≤1 on day 90
day 90
Secondary Outcomes (6)
mRS score on day 90
day 90
Changes of NIHSS score from baseline on day 14
day 14
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
Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90
day 14, 30, 90
- +1 more secondary outcomes
Study Arms (2)
Compound Edaravone
EXPERIMENTALCompound Edaravone Injection 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days
Edaravone
ACTIVE COMPARATOREdaravone Injection 30 mg/dose, one dose every 12 hours, continues for 14 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Navy General Hospital of The Chinese PLA
Beijing, Beijing Municipality, 100048, China
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541001, China
Liuzhou Worker's Hospital
Liuchow, Guangxi, 545005, China
Nanning Second People's Hospital
Nanning, Guangxi, 530031, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004, China
Cangzhou Central Hospital
Cangzhou, Hebei, 061000, China
The Second Affiliated Hospital of Haerbin Medical University
Haerbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410005, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 421001, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 014010, China
The Third Affiliated Hospital of Inner Mongolia Medical University
Baotou, Inner Mongolia, 014010, China
Central Hospital of Baotou
Baotou, Inner Mongolia, 014040, China
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, 010017, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010050, China
Huai'an First Affiliated Hospital of Nanjing Medical University
Huai'an, Jiangsu, 223300, China
Lianyungang First People's Hospital
Lianyungang, Jiangsu, 222002, China
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
Zhongda Hospital,Southeast University
Nanjing, Jiangsu, 210009, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
Nanjing Brain Hospital
Nanjing, Jiangsu, 210029, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, 221006, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001, China
Yangzhou No.1 People's Hospital
Yangzhou, Jiangsu, 225001, China
The Second Hospital of Jilin University
Changchun, Jilin, 130041, China
The Forth Hospital of Jilin University
Siping, Jilin, 130011, China
Siping Central Hospital
Siping, Jilin, 136000, China
The General Hospital of Shenyang Military, Chinese PLA
Shenyang, Liaoning, 110016, China
The Sceond Hospital of Shandong University
Jinan, Shandong, 250033, China
Liaocheng People's Hospital
Liaocheng, Shandong, 252000, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266011, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003, China
Yangpu Hospital, Tongji University
Shanghai, Shanghai Municipality, 200090, China
The Second Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300000, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, 300060, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211, China
Lishui People's Hospital
Lishui, Zhejiang, 323000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Related Publications (1)
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.
PMID: 33588596DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yongjun Wang, MD
Beijing Tiantan Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2015
First Posted
April 30, 2015
Study Start
May 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
January 16, 2017
Record last verified: 2017-01