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Danhong Injection in the Treatment of Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT01677208
Recruitment Status : Recruiting
First Posted : August 31, 2012
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
China Food and Drug Administration
Information provided by (Responsible Party):
Zhong Wang, China Academy of Chinese Medical Sciences

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

Condition or disease Intervention/treatment Phase
Acute Stroke Drug: Danhong injection Procedure: Standard medical care Drug: placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1513 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Acute Ischemic Stroke
Study Start Date : December 2012
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Danhong injection
Based on the standard medical care, 40ml of Danhong injection, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.
 Drug: Danhong injection
A kind of injection made from two kind of Chinese herbs: Salvia miltiorrhiza and Safflower. 40ml Danhong injection added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion

Procedure: Standard medical care
Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2010), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.
Placebo Comparator: placebo
Based on the standard medical care, 40ml of 0.9% saline as the placebo, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.
 Procedure: Standard medical care
Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2010), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.

Drug: placebo
0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion.


Outcome Measures
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Primary Outcome Measures :
  1. Modified Rankin Scale 0-1 (favourable outcome) at Day 90 [ Time Frame: Day 90 ]

Secondary Outcome Measures :
  1. The Score of effect on symptoms of "Xueyue Zheng"(Blood Stasis syndrome) [ Time Frame: Day 0, Day7, Day 14, Day 30, Day 60, Day 90 ]
  2. Barthel Index score ≥90 [ Time Frame: Day 0, Day7, Day 14, Day 30, Day 60, Day 90 ]
  3. NIH stroke scale(NIHSS) [ Time Frame: Day 0, Day7, Day 14, Day 30, Day 60, Day 90 ]
    The improvement of the NIHSS score ≥4 or the NIHSS score of 0 to 1

  4. EQ-5D scale [ Time Frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ]
  5. Global disability on mRS at Day 90. [ Time Frame: Day 90 ]
    The proportion of patients with mRS ≥3 at Day 90.

  6. Incidence of new-onset major vascular events in 90 days [ Time Frame: Day 90 ]
    Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.

  7. Overall mortality at day 90 [ Time Frame: Day 90 ]
  8. Incidence of severe hemorrhages in 90 days [ Time Frame: Day 90 ]
    The definition of "Severe hemorrhages" is in accordance with the GUSTO bleeding criteria, including fatal intracranial hemorrhage (ICH), symptomatic intracerebral hemorrhage (sICH) or which could result in substantial hemodynamic compromise requiring treatment.

  9. Incidence of moderate hemorrhages in 90 days [ Time Frame: Day 90 ]
    The definition of "moderate hemorrhages" is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise.

  10. Documentation of adverse events (AEs) and serious AEs [ Time Frame: 90 days ]

Other Outcome Measures:
  1. The changes on the profiles of micro-RNA in 96 patients selected from certain centers [ Time Frame: Day 0, Day 14, Day 90 ]
  2. The changes on the expression profiles of mRNA in 96 patients selected from certain centers [ Time Frame: Day 0, Day 14, Day 90 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677208


Contacts
Contact: Zhong Wang, Professor 8610-64014411 ext 3308 zhonw@vip.sina.com
Contact: Jun Liu, Ph.D. 8610-64014411 ext 2805 franlj1104@aliyun.com

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Locations
China, Beijing
The Second Artillery General Hospital of Chinese People's Liberation Army Completed
Beijing, Beijing, China, 100088
China, Chongqing
Xinqiao Hospital of Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400037
Contact: Qing-wu Yang, M.D.         
Principal Investigator: Qing-wu Yang, M.D.         
Chongqing Three Gorges Central Hospital Recruiting
Chongqing, Chongqing, China, 404000
Contact: Shu-qiong Zhang, Professor         
Principal Investigator: Shu-qiong Zhang, Professor         
China, Guangdong
Guangdong No.2 Provincial People's Hospital Recruiting
Guangzhou, Guangdong, China, 510317
Contact: Xin-tong Liu, M.D.         
Principal Investigator: Xin-tong Liu, M.D.         
Guangzhou hospital of integrated Chinese and Western medicine Recruiting
Guangzhou, Guangdong, China, 510813
Contact: Chao-jun Chen, M.D.         
Principal Investigator: Chao-jun Chen         
China, Hebei
Affiliated Hospital of Chengde Medical University Recruiting
Chengde, Hebei, China, 067000
Contact: Yan-jun Gao         
Principal Investigator: Yan-jun Gao         
Handan Central Hospital Recruiting
Handan, Hebei, China, 056001
Contact: Jun-tao Li    86-310-2112562      
Principal Investigator: Jun-tao Li         
The Second Affiliated Hospital of Xingtai Medical College Active, not recruiting
Xingtai, Hebei, China, 054099
China, Henan
The First Affiliated Hospital of Henan University of T.C.M. Recruiting
Zhengzhou, Henan, China, 450000
Contact: Xin-zhi Wang, Professor    86371-66201040    znqznq@163.com   
Principal Investigator: Xin-zhi Wang, Professor         
People's Hospital of Zhengzhou Recruiting
Zhengzhou, Henan, China, 450003
Contact: Lai-hui Feng, Professor         
Principal Investigator: Lai-hui Feng, Professor         
Zhengzhou NO.7 People's Hospital Recruiting
Zhengzhou, Henan, China, 450006
Contact: Jun-xing Dong, Professor         
Principal Investigator: Jun-xing Dong, Professor         
China, Hubei
The Second Central Hospital of Baoding City Recruiting
Baoding, Hubei, China, 072750
Contact: Shuang-xia Du         
Principal Investigator: Shuang-xia Du         
The Central Hospital of Wuhan Recruiting
Wuhan, Hubei, China, 430014
Contact: Lin-hong Zhang, Professor         
Principal Investigator: Lin-hong Zhang, Professor         
Zhongnan Hospital of Wuhan University Recruiting
Wuhan, Hubei, China, 430030
Contact: Yu-min Liu, M.D.    8627-67813086      
Principal Investigator: Yu-min Liu, M.D.         
Zhongshan Hospital of Hubei Province Recruiting
Wuhan, Hubei, China, 430033
Contact: Xiao-rong Deng, Professor       xiaorong9596@aliyun.com   
Principal Investigator: Xiao-rong Deng, Professor         
Fifth Hospital in Wuhan Recruiting
Wuhan, Hubei, China, 430050
Contact: Ming Li         
Principal Investigator: Ming Li         
Renmin Hospital of Wuhan University Recruiting
Wuhan, Hubei, China, 430060
Contact: Zhao-hui Zhang, M.D.    8627-88041919 ext 82143      
Principal Investigator: Zhao-hui Zhang, M.D.         
Hubei Provincial Hospital of T.C.M. Withdrawn
Wuhan, Hubei, China, 430061
Tianyou Hospital Affiliated to Wuhan University of Science & Technology Recruiting
Wuhan, Hubei, China, 430064
Contact: Jun Peng         
Principal Investigator: Jun Peng         
China, Hunan
Changsha Central Hospital Recruiting
Changsha, Hunan, China, 410004
Contact: Zhu-xin Liu, Professor    86-13975128927      
Principal Investigator: Zhu-xin Liu, Professor         
The First Hospital of Changsha Recruiting
Changsha, Hunan, China, 410005
Contact: Ai-min Wang, Professor       wangaimindoc@163.com   
Principal Investigator: Ai-min Wang, Professor         
The second people's hospital of Hunan Province Recruiting
Changsha, Hunan, China, 410007
Contact: Qiu-ting Liu, Professor       13974809911@163.com   
Principal Investigator: Qiu-ting Liu, Professor         
Xiangya Hospital Central-south University Completed
Changsha, Hunan, China, 410008
China, Jiangsu
Nanjing Hospital of T.C.M. Terminated
Nanjing, Jiangsu, China, 210001
The Second Affiliated Hospital of Nanjing Medical University Completed
Nanjing, Jiangsu, China, 210003
Nanjing Drum Tower Hospital Terminated
Nanjing, Jiangsu, China, 210008
China, Jilin
Jilin Province People's Hospital Recruiting
Changchun, Jilin, China, 130021
Contact: Hong-xia Sun, Professor         
Principal Investigator: Hong-xia Sun, Professor         
The Affiliated Hopital to Changchun University of Chinese Medicine Terminated
Changchun, Jilin, China, 130021
The First Hospital Affiliated to Jilin University Recruiting
Changchun, Jilin, China, 130021
Contact: Jia-chun Feng, M.D.         
Principal Investigator: Jia-chun Feng, M.D.         
China-Japan Union Hospital of Jilin University Recruiting
Changchun, Jilin, China, 130033
Contact: Hong Yang, Professor         
Principal Investigator: Hong Yang, Professor         
The Second Hospital of Jilin University Terminated
Changchun, Jilin, China, 130041
Liaoyuan Traditional Chinese Medical Hospital Recruiting
Liaoyuan, Jilin, China, 136299
Contact: Hong-wei Dai         
Principal Investigator: Hong-wei Dai         
China, Liaoning
Anshan Central Hospital Recruiting
Anshan, Liaoning, China, 114001
Contact: Zhen Jiao         
Principal Investigator: Zhen Jiao         
Affiliated Zhongshan Hospital of Dalian University Recruiting
Dalian, Liaoning, China, 116001
Contact: Qiang Ma, Professor    86411-62893581    mqiang2100@yahoo.com.cn   
Principal Investigator: Qiang Ma, Professor         
Panjin Central Hospital Recruiting
Panjin, Liaoning, China, 124013
Contact: Yan-hua Zhou         
Principal Investigator: Yan Hua         
People's Liberation Army No.202 Hospital Recruiting
Shenyang, Liaoning, China, 110003
Contact: Zhi-lin Jiang, Professor         
Principal Investigator: Zhi-lin Jiang, Professor         
The General Hospital of Shenyang Military Recruiting
Shenyang, Liaoning, China, 110016
Contact: Hui-sheng Chen, M.D.         
Principal Investigator: Hui-sheng Chen, M.D.         
The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Withdrawn
Shenyang, Liaoning, China, 110034
People's Liberation Army No.463 Hospital Recruiting
Shenyang, Liaoning, China, 110046
Contact: Shu-hang Feng, M.D.         
Principal Investigator: Shu-hang Feng, M.D.         
China, Neimenggu
Affiliated Hospital of Chifeng University Recruiting
Chifeng, Neimenggu, China, 024005
Contact: Wei-li Zhao         
Principal Investigator: Wei-li Zhao         
China, Shanghai
Xuhui District Central Hospital of Shanghai City Withdrawn
Shanghai, Shanghai, China, 200031
The Sixth People's Hospital of Shanghai City Withdrawn
Shanghai, Shanghai, China, 200233
China, Shanxi
Fenyang Hospital of Shanxi Province Recruiting
Lvliang, Shanxi, China, 032299
Contact: Bao-ai Wang         
Principal Investigator: Bao-ai Wang         
The Second Affiliated Hospital to Shanxi Medical University Recruiting
Taiyuan, Shanxi, China, 030001
Contact: Guang-lai Li, Professor    86-13703587193      
Principal Investigator: Guang-lai Li, Professor         
Shanxi Province Hospital of T.C.M. Terminated
Xi'an, Shanxi, China, 710003
The PLA Fourth Fifty-one Hospital Recruiting
Xi'an, Shanxi, China, 710054
Contact: Li-yi Chi, Professor       1173319088@qq.com   
Principal Investigator: Li-yi Chi, Professor         
Shanxi Provincial People's Hospital Recruiting
Xi'an, Shanxi, China, 710068
Contact: Qian Yang, Professor       YangQdoctor@163.com   
Principal Investigator: Qian Yang, Professor         
Affiliated Hospital of Shanxi University of Chinese Medicine Recruiting
Xianyang, Shanxi, China, 712000
Contact: Yong-mei Yan, Professor    86-13609216551      
Principal Investigator: Yong-mei Yan, Professor         
The Second Affiliated Hospital of Shanxi University of T.C.M. Recruiting
Xianyang, Shanxi, China, 712000
Contact: Ju-mei Du         
Principal Investigator: Ju-mei Du         
China, Sichuan
Teaching Hospital of Chengdu University of Traditional Chinese Medicine Recruiting
Chengdu, Sichuan, China, 610072
Contact: Yun Lu       luyun999@126.com   
Principal Investigator: Yun Lu         
China, Tianjin
Tianjin Medical University General Hospital Active, not recruiting
Tianjin, Tianjin, China, 300052
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Recruiting
Tianjin, Tianjin, China, 300193
Contact: Zhi-hong Meng, M.D.    86-18722699933      
Principal Investigator: Zhi-hong Meng, M.D.         
China, Zhejiang
The First Affiliated Hospital of College of Medicine, Zhejiang University Withdrawn
Hangzhou, Zhejiang, China, 310003
Xin Hua Hospital of Zhejiang Province Recruiting
Hangzhou, Zhejiang, China, 310005
Contact: Bin Xu, Professor    86-571-85288221      
Principal Investigator: Bin Xu, Professor         
Zhejiang Provincial Hospital of T.C.M. Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Qun Hou, Professor       houqun168@163.com   
Principal Investigator: Qun Hou, Professor         
Zhejiang Provincial People's Hospital Recruiting
Hangzhou, Zhejiang, China, 310014
Contact: Yu Geng, M.D.       gengy2004@126.com   
Principal Investigator: Yu Geng, M.D.         
Huzhou Central Hospital Active, not recruiting
Huzhou, Zhejiang, China, 313003
China
Peking University First Hospital Terminated
Beijing, China, 100034
Peking University of People's Hospital Withdrawn
Beijing, China, 100044
Tiantan Hospital Affiliated to Capital Medical University Recruiting
Beijing, China, 100050
Contact: Xing-quan Zhao, M.D.    010-67098891    zxq@vip.163.com   
Principal Investigator: Xing-quan Zhao, M.D.         
Xuan Wu Hospital Affiliated to Capital Medical University Recruiting
Beijing, China, 100053
Contact: Li Gao, Professor    8610-83198728    xuanwugaoli@126.com   
Principal Investigator: Li Gao, Professor         
Sponsors and Collaborators
China Academy of Chinese Medical Sciences
China Food and Drug Administration
Investigators
Principal Investigator: Zhong Wang, Professor Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences
Principal Investigator: Xing-quan Zhao, Professor Beijing Tiantan Hospital
Study Chair: Yong-yan Wang, Professor Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences
Study Director: Xiao-xi Du, Professor China Food and Drug Administration
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Zhong Wang, Professor, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01677208     History of Changes
Other Study ID Numbers: DH20120423
First Posted: August 31, 2012    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Keywords provided by Zhong Wang, China Academy of Chinese Medical Sciences:
Acute Ischemic Stroke
Randomized Controlled Trial
Traditional Chinese Medicine

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases