Danhong Injection in the Treatment of Acute Ischemic Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by China Academy of Chinese Medical Sciences
Sponsor:
Collaborator:
China: State Food and Drug Administration
Information provided by (Responsible Party):
Zhong Wang, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01677208
First received: August 29, 2012
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Acute Stroke
Drug: Danhong injection
Procedure: Standard medical care
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • Modified Rankin Scale 0-1 (favourable outcome) at Day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Barthel Index score ≥90 [ Time Frame: Day 0, Day7, Day 14, Day 30, Day 60, Day 90 ] [ Designated as safety issue: No ]
  • NIH stroke scale(NIHSS) [ Time Frame: Day 0, Day7, Day 14, Day 30, Day 60, Day 90 ] [ Designated as safety issue: No ]
    The improvement of the NIHSS score ≥4 or the NIHSS score of 0 to 1

  • EQ-5D scale [ Time Frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ] [ Designated as safety issue: No ]
  • Global disability on mRS at Day 90. [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    The proportion of patients with mRS ≥3 at Day 90.

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

  • Overall mortality at day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]
  • Incidence of severe hemorrhages in 90 days [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]
    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.

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

  • Documentation of adverse events (AEs) and serious AEs [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • The changes on the profiles of micro-RNA in 96 patients selected from certain centers [ Time Frame: Day 0, Day 14, Day 90 ] [ Designated as safety issue: Yes ]
  • The changes on the expression profiles of mRNA in 96 patients selected from certain centers [ Time Frame: Day 0, Day 14, Day 90 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 846
Study Start Date: December 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677208

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

  Hide Study Locations
Locations
China, Beijing
Second Artillery General Hospital of People's Liberation Army Recruiting
Beijing, Beijing, China, 100088
Contact: Lei Wang, Professor    8610-66343392    hellowanglei068@163.com   
Principal Investigator: Lei Wang         
China, Chongqing
Chongqing Three Gorges Central Hospital Recruiting
Chongqing, Chongqing, China, 404000
Contact: Shu-qiong Zhang, Professor         
Principal Investigator: Shu-qiong Zhang, Professor         
Xinqiao Hospital of Third Military Medical University Not yet recruiting
Chongqing, Chongqing, China, 400037
Contact: Qing-wu Yang, M.D.         
Principal Investigator: Qing-wu Yang, M.D.         
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         
China, Hubei
Hubei Provincial Hospital of T.C.M. Active, not recruiting
Wuhan, Hubei, China, 430061
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.         
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.         
China, Hunan
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         
Changsha Central Hospital Recruiting
Changsha, Hunan, China, 410004
Contact: Zhu-xin Liu, Professor    86-13975128927      
Principal Investigator: Zhu-xin Liu, Professor         
Xiangya Hospital Central-south University Active, not recruiting
Changsha, Hunan, China, 410008
The First Hospital of Changsha Recruiting
Changsha, Hunan, China, 410005
Contact: Ai-min Wang, Professor       wangaimindoc@163.com   
Principal Investigator: Ai-min Wang, Professor         
China, Jiangsu
The Second Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210003
Contact: Zhi-qiang Gao, Professor    86-18951762858      
Principal Investigator: Zhi-qiang Gao, Professor         
Nanjing Drum Tower Hospital Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Yun Xu, M.D.    8625-83305616 ext 20802    xuyunz@hotmail.com   
Principal Investigator: Yun Xu, M.D.         
Nanjing Hospital of T.C.M. Recruiting
Nanjing, Jiangsu, China, 210001
Contact: Shu-ping Cao, Professor    86-13951014652      
Principal Investigator: Shu-ping Cao, Professor         
China, Jilin
The Second Hospital of Jilin University Recruiting
Changchun, Jilin, China, 130041
Contact: Ting-min Yu, M.D.    86-431-88796816      
Principal Investigator: Ting-min Yu, M.D.         
The First Hospital Affiliated to Jilin University Active, not recruiting
Changchun, Jilin, China, 130021
Jilin Province People's Hospital Recruiting
Changchun, Jilin, China, 130021
Contact: Hong-xia Sun, Professor         
Principal Investigator: Hong-xia Sun, Professor         
China, Liaoning
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         
China, Shanghai
The Sixth People's Hospital of Shanghai City Not yet recruiting
Shanghai, Shanghai, China, 200233
Contact: Qing-ping Huo, Professor         
Principal Investigator: Qing-ping Huo, Professor         
Xuhui District Central Hospital of Shanghai City Active, not recruiting
Shanghai, Shanghai, China, 200031
China, Shanxi
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. Recruiting
Xi'an, Shanxi, China, 710003
Contact: Zu-cheng Han, Professor       13759968645@139.com   
Principal Investigator: Zu-cheng Han, Professor         
Shanxi Provincial People's Hospital Recruiting
Xi'an, Shanxi, China, 710068
Contact: Qian Yang, Professor       YangQdoctor@163.com   
Principal Investigator: Qian Yang, Professor         
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         
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         
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
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
Zhejiang Provincial Hospital of T.C.M. Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Qun Hou, Professor       houqun168@163.com   
Principal Investigator: Qun Hou, Professor         
Xin Hua Hospital of Zhejiang Province Recruiting
Hangzhou, Zhejiang, China, 310005
Contact: Bin Xu, Professor    86-571-85288221      
Principal Investigator: Bin Xu, Professor         
The First Affiliated Hospital of College of Medicine, Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Ben-yan Luo, M.D.       luobenyan@zju.edu.cn   
Principal Investigator: Ben-yan Luo, M.D.         
Zhejiang Provincial People's Hospital Recruiting
Hangzhou, Zhejiang, China, 310014
Contact: Yu Geng, M.D.       gengy2004@126.com   
Principal Investigator: Yu Geng, M.D.         
China
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         
Peking University First Hospital Recruiting
Beijing, China, 100034
Contact: Xue-zhi Zhang, Professor    010-83572634    zhang.xuezhi@263.net   
Principal Investigator: Xue-zhi Zhang         
Peking University People's Hospital Active, not recruiting
Beijing, China, 100044
Sponsors and Collaborators
China Academy of Chinese Medical Sciences
China: State 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: State Food and Drug Administration
  More Information

No publications provided

Responsible Party: Zhong Wang, Professor, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01677208     History of Changes
Other Study ID Numbers: DH20120423
Study First Received: August 29, 2012
Last Updated: July 9, 2014
Health Authority: China: Ministry of Science and Technology

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

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

ClinicalTrials.gov processed this record on July 24, 2014