Clinical trial NCT01677208: Danhong Injection in the Treatment of Acute Ischemic Stroke
Official title: A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Stroke
Keywords: Acute Ischemic Stroke
Randomized Controlled Trial
Traditional Chinese Medicine
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: China Food and Drug Administration
First posted: 2012-08-31
Enrollment: 1503
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Danhong injection is effective in the treatment of acute ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* Female or male inpatients
* Age: 18 - 70 years.
* Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze, vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes hemorrhage.
* Clinical diagnosis of "Xueyu Zheng" (Blood Stasis Syndrome) as the scores of Chinese medicine symptoms scales of "Xueyu Zheng" in ischemic stroke ≥ 20. The Chinese medicine symptoms scales of "Xueyu Zheng" is defined as following (1)hemiplegia-10,(2)numbness of limbs-10，(3) dark face-9,(4)purple or dark lip-8,(5)Roughness of skin-4, (6) pain with fixed point-5, (7) purple or dark tongue-10,(8)ecchymosis on tongue-10,(9)purple sublingual vessel-10,(10)varicose sublingual vessel-8,(11)unsmooth pulse-8,(12)intermittent pulse-1.
* Onset of symptoms in 1 week prior to initiation of administration of study drug.
* Clinical diagnosis of cerebral anterior circulation obstruction.
* 4≤NIHSS\<20.
* Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable, according to the regulatory and legal requirements of the participating centers.

Exclusion Criteria:

* Evidence of intracranial hemorrhage (ICH) or other cerebral diseases (eg.vascular malformation, tumor, abscess or multiple sclerosis etc.)on the CT-or MRI-scan.
* Patients with thrombolysis or endovascular treatment.
* Known history of allergy or suspected allergic to the drug.
* Blood glucose 2.8 or \> 16.8 mmol / l under the treatment of diabetes or with severe complications due to diabetes (eg. peripheral neuropathy, diabetic gangrene).
* Liver function impairment with the value of ALT or AST over 1.5-fold of normal value.
* Renal dysfunction with the value of serum creatinine over 1.5-fold of normal value.
* Severe cardiac dysfunction on echocardiogram or the grade of heart function over Ⅲ grade.
* History of prior stroke with mRS ≥2.
* Complicated with atrial fibrillation.
* Severe stroke as assessed by appropriate imaging techniques (eg. massive cerebral infarction including more than one lobe of brain or over 1/3 of blood-supply area of middle cerebral artery).
* Prior disable patients.
* Hemorrhagic tendency or recent severe or dangerous bleeding in 3 months.
* Suspected addicted into alcohol or drug abuse.
* With severe complications that would make the condition more complicated assessed by the investigator.
* Woman with pregnancy, lactation or positive result of pregnancy test, or women who want to be pregnant in recent 6 months.
* Woman who is under menstrual period.
* Patient who is participating in other trials or has been participated in other trials in recent 3 months.

Primary outcomes:
measure: Modified Rankin Scale 0-1 (favourable outcome) at Day 90
timeFrame: Day 90
Secondary outcomes:
measure: The Score of effect on symptoms of "Xueyue Zheng"(Blood Stasis syndrome)
timeFrame: Day 0, Day7, Day 14, Day 30, Day 60, Day 90
measure: Barthel Index score ≥90
timeFrame: Day 0, Day7, Day 14, Day 30, Day 60, Day 90
measure: NIH stroke scale(NIHSS)
timeFrame: Day 0, Day7, Day 14, Day 30, Day 60, Day 90
measure: EQ-5D scale
timeFrame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
measure: Global disability on mRS at Day 90.
timeFrame: Day 90
measure: Incidence of new-onset major vascular events in 90 days
timeFrame: Day 90
measure: Overall mortality at day 90
timeFrame: Day 90
measure: Incidence of severe hemorrhages in 90 days
timeFrame: Day 90
measure: Incidence of moderate hemorrhages in 90 days
timeFrame: Day 90
measure: Documentation of adverse events (AEs) and serious AEs
timeFrame: 90 days
Other outcomes:
measure: The changes on the profiles of micro-RNA in 96 patients selected from certain centers
timeFrame: Day 0, Day 14, Day 90
measure: The changes on the expression profiles of mRNA in 96 patients selected from certain centers
timeFrame: Day 0, Day 14, Day 90
Locations:
city: Beijing
country: China
facility: The Second Artillery General Hospital of Chinese People's Liberation Army
state: Beijing
city: Chongqing
country: China
facility: Xinqiao Hospital of Third Military Medical University
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Three Gorges Central Hospital
state: Chongqing
city: Guangzhou
country: China
facility: Guangdong No.2 Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou hospital of integrated Chinese and Western medicine
state: Guangdong
city: Shenzhen
country: China
facility: The Second People's Hospital of Shenzhen
state: Guangdong
city: Baoding
country: China
facility: The Second Central Hospital of Baoding City
state: Hebei
city: Chengde
country: China
facility: Affiliated Hospital of Chengde Medical University
state: Hebei
city: Handan
country: China
facility: Handan Central Hospital
state: Hebei
city: Harbin
country: China
facility: The Second Affiliated Hopital of Harbin Medical University
state: Helongjiang
city: Luoyang
country: China
facility: The Second Chinese Medical Hospital of Luoyang City
state: Henan
city: Nanyang
country: China
facility: Nanyang T.C.M. Hospital
state: Henan
city: Nanyang
country: China
facility: Nanshi Hospital of Nanyang
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of T.C.M.
state: Henan
city: Zhengzhou
country: China
facility: People's Hospital of Zhengzhou
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou NO.7 People's Hospital
state: Henan
city: Zhoukou
country: China
facility: Zhoukou Hospital of T.C.M.
state: Henan
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Zhongshan Hospital of Hubei Province
state: Hubei
city: Wuhan
country: China
facility: Fifth Hospital in Wuhan
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Tianyou Hospital Affiliated to Wuhan University of Science & Technology
state: Hubei
city: Wuhan
country: China
facility: Huangpi District Hospital of T.C.M.
state: Hubei
city: Changsha
country: China
facility: Changsha Central Hospital
state: Hunan
city: Changsha
country: China
facility: The First Hospital of Changsha
state: Hunan
city: Changsha
country: China
facility: The second people's hospital of Hunan Province
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central-south University
state: Hunan
city: Nanjing
country: China
facility: Nanjing Hospital of T.C.M.
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Changchun
country: China
facility: Jilin Province People's Hospital
state: Jilin
city: Changchun
country: China
facility: The Affiliated Hopital to Changchun University of Chinese Medicine
state: Jilin
city: Changchun
country: China
facility: The First Hospital Affiliated to Jilin University
state: Jilin
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Liaoyuan
country: China
facility: Liaoyuan Traditional Chinese Medical Hospital
state: Jilin
city: Anshan
country: China
facility: Anshan Central Hospital
state: Liaoning
city: Dalian
country: China
facility: Affiliated Zhongshan Hospital of Dalian University
state: Liaoning
city: Dandong
country: China
facility: Dandong First Hospital
state: Liaoning
city: Panjin
country: China
facility: Panjin Central Hospital
state: Liaoning
city: Shenyang
country: China
facility: People's Liberation Army No.202 Hospital
state: Liaoning
city: Shenyang
country: China
facility: The General Hospital of Shenyang Military
state: Liaoning
city: Shenyang
country: China
facility: People's Liberation Army No.463 Hospital
state: Liaoning
city: Chifeng
country: China
facility: Affiliated Hospital of Chifeng University
state: Neimenggu
city: Luliang
country: China
facility: Fenyang Hospital of Shanxi Province
state: Shanxi
city: Taiyuan
country: China
facility: The Second Affiliated Hospital to Shanxi Medical University
state: Shanxi
city: Xi'an
country: China
facility: Shanxi Province Hospital of T.C.M.
state: Shanxi
city: Xi'an
country: China
facility: The PLA Fourth Fifty-one Hospital
state: Shanxi
city: Xi'an
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Xianyang
country: China
facility: Affiliated Hospital of Shanxi University of Chinese Medicine
state: Shanxi
city: Xianyang
country: China
facility: The Second Affiliated Hospital of Shanxi University of T.C.M.
state: Shanxi
city: Chengdu
country: China
facility: Teaching Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
city: Chengdu
country: China
facility: The First Affiliated Hopital of Chengdu Medical College
state: Sichuan
city: Tianjin
country: China
facility: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
city: Hangzhou
country: China
facility: Xin Hua Hospital of Zhejiang Province
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial Hospital of T.C.M.
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Huzhou
country: China
facility: Huzhou Central Hospital
state: Zhejiang
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Tiantan Hospital Affiliated to Capital Medical University
city: Beijing
country: China
facility: Xuan Wu Hospital Affiliated to Capital Medical University
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Zhong Wang, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Xing-quan Zhao, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yong-yan Wang, Professor
role: STUDY_CHAIR
affiliation: China Food and Drug Administration
name: Xiao-xi Du, Professor
role: STUDY_DIRECTOR
References:
citation: Li B, Wang Y, Lu J, Liu J, Yuan Y, Yu Y, Wang P, Zhao X, Wang Z. Evaluating the effects of Danhong injection in treatment of acute ischemic stroke: study protocol for a multicenter randomized controlled trial. Trials. 2015 Dec 9;16:561. doi: 10.1186/s13063-015-1076-4.