Danhong Injection in the Treatment of Acute Ischemic Stroke

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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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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):

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.

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
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