Compound Edaravone Injection for Acute Ischemic Stroke
1 other identifier
interventional
400
1 country
28
Brief Summary
- 1.To investigate the efficacy and safety of multi-doses Compound Edaravone Injection versus Edaravone Injection for acute ischemic stroke patients;
- 2.To provide evidence for the design of Compound Edaravone Injection Phase III trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2013
Shorter than P25 for phase_2
28 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
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 22, 2013
CompletedFirst Posted
Study publicly available on registry
August 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedJuly 3, 2015
July 1, 2015
1.3 years
August 22, 2013
July 1, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
mRS score on day 90
day 90
Change from baseline NIHSS score on day 14
day 14
Secondary Outcomes (4)
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
The Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90
day 14, 30, 90
Stroke Impact Scale (SIS) score on day 90
day 90
Study Arms (4)
Low-dose group
EXPERIMENTALCompound Edaravone Injection, 12.5mg/dose (Edaravone 10mg, (+)-Borneol 2.5mg), one dose every 12 hours, continue for 14 days
Medium-dose group
EXPERIMENTALCompound Edaravone Injection, 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days
High-dose group
EXPERIMENTALCompound Edaravone Injection, 62.5mg/dose (Edaravone 50mg, (+)-Borneol 12.5mg), one dose every 12 hours, continue for 14 days
Control group
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 to 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;
- Creatinine clearance is less than 30 ml/min or previously known severe renal diseases;
- Therapeutic neuroprotective agents have been applied after onset, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
- Arterial or venous thrombolytic therapy has been applied after onset;
- With malignant tumors or receiving concurrent antitumor treatment;
- With severe systemic disease, life expectancy is less than 90 days;
- Pregnant or lactating women;
- Participate in other clinical studies within 30 days before randomization;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Navy General Hospital of The Chinese PLA
Beijing, Beijing Municipality, 100048, China
Beijing Tiantan Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 100050, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
The First Affiliated Hospital of Third Military Medical University of Chinese PLA
Chongqing, Chongqing Municipality, 400038, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Hebei General Hospital
Shijiazhuang, Hebei, 050051, China
The Second Affiliated Hospital of Haerbin Medical University
Haerbin, Heilongjiang, 150001, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410005, China
Central Hospital of Baotou
Baotou, Inner Mongolia, 014040, China
Nanjing First Hospital
Nanjing, Jiangsu, 210006, 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
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
The General Hospital of Shenyang Military, Chinese PLA
Shenyang, Liaoning, 110016, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
The Second Hospital of Shandong University
Jinan, Shandong, 250033, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266011, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
The First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
The Second Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, 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
Related Publications (1)
Xu J, Wang Y, Wang A, Gao Z, Gao X, Chen H, Zhou J, Zhao X, Wang Y. Safety and efficacy of Edaravone Dexborneol versus edaravone for patients with acute ischaemic stroke: a phase II, multicentre, randomised, double-blind, multiple-dose, active-controlled clinical trial. Stroke Vasc Neurol. 2019 Apr 22;4(3):109-114. doi: 10.1136/svn-2018-000221. eCollection 2019 Sep.
PMID: 31709115DERIVED
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 2
- 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
August 22, 2013
First Posted
August 27, 2013
Study Start
August 1, 2013
Primary Completion
December 1, 2014
Study Completion
February 1, 2015
Last Updated
July 3, 2015
Record last verified: 2015-07