Clinical trial NCT01929096: Compound Edaravone Injection for Acute Ischemic Stroke
Official title: Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Multi-dose, Parallel, and Controlled Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-27
Enrollment: 400
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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;
* The investigators consider the patients are not suitable for this trial.

Primary outcomes:
measure: mRS score on day 90
timeFrame: day 90
measure: Change from baseline NIHSS score on day 14
timeFrame: day 14
Secondary outcomes:
measure: The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90
timeFrame: day 14, 30, 90
measure: The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90
timeFrame: day 14, 30, 90
measure: The Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90
timeFrame: day 14, 30, 90
measure: Stroke Impact Scale (SIS) score on day 90
timeFrame: day 90
Other outcomes:
Locations:
city: Beijing
country: China
facility: Navy General Hospital of The Chinese PLA
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital affiliated to Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Third Military Medical University of Chinese PLA
state: Chongqing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Haerbin
country: China
facility: The Second Affiliated Hospital of Haerbin Medical University
state: Heilongjiang
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Baotou
country: China
facility: Central Hospital of Baotou
state: Inner Mongolia
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Shenyang
country: China
facility: The General Hospital of Shenyang Military, Chinese PLA
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Taiyuan
country: China
facility: The First Affiliated Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: The Second Affiliated Hospital of Shanxi Medical University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin People's Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Tianjin
Study officials:
affiliation: Beijing Tiantan Hospital
name: Yongjun Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.