Danhong Injection in the Treatment of Acute Ischemic Stroke

Acute Stroke Clinical Trial

Official title:

A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677208
• Other study ID #: DH20120423
• Status: Completed
• Phase: Phase 4
• Start date: March 13, 2013
• Est. completion date: March 27, 2019

Study information

• Verified date: June 2022
• Source: China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1503
• Est. completion date: March 27, 2019
• Est. primary completion date: March 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ? 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.

Related Conditions & MeSH terms

• Acute Stroke
• Ischemic Stroke
• Stroke

Intervention

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.

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.

Locations

Country	Name	City	State
China	Anshan Central Hospital	Anshan	Liaoning
China	The Second Central Hospital of Baoding City	Baoding	Hebei
China	Peking University First Hospital	Beijing
China	The Second Artillery General Hospital of Chinese People's Liberation Army	Beijing	Beijing
China	Tiantan Hospital Affiliated to Capital Medical University	Beijing
China	Xuan Wu Hospital Affiliated to Capital Medical University	Beijing
China	China-Japan Union Hospital of Jilin University	Changchun	Jilin
China	Jilin Province People's Hospital	Changchun	Jilin
China	The Affiliated Hopital to Changchun University of Chinese Medicine	Changchun	Jilin
China	The First Hospital Affiliated to Jilin University	Changchun	Jilin
China	The Second Hospital of Jilin University	Changchun	Jilin
China	Changsha Central Hospital	Changsha	Hunan
China	The First Hospital of Changsha	Changsha	Hunan
China	The second people's hospital of Hunan Province	Changsha	Hunan
China	Xiangya Hospital Central-south University	Changsha	Hunan
China	Affiliated Hospital of Chengde Medical University	Chengde	Hebei
China	Teaching Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan
China	The First Affiliated Hopital of Chengdu Medical College	Chengdu	Sichuan
China	Affiliated Hospital of Chifeng University	Chifeng	Neimenggu
China	Chongqing Three Gorges Central Hospital	Chongqing	Chongqing
China	Xinqiao Hospital of Third Military Medical University	Chongqing	Chongqing
China	Affiliated Zhongshan Hospital of Dalian University	Dalian	Liaoning
China	Dandong First Hospital	Dandong	Liaoning
China	Guangdong No.2 Provincial People's Hospital	Guangzhou	Guangdong
China	Guangzhou hospital of integrated Chinese and Western medicine	Guangzhou	Guangdong
China	Handan Central Hospital	Handan	Hebei
China	Xin Hua Hospital of Zhejiang Province	Hangzhou	Zhejiang
China	Zhejiang Provincial Hospital of T.C.M.	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	The Second Affiliated Hopital of Harbin Medical University	Harbin	Helongjiang
China	Huzhou Central Hospital	Huzhou	Zhejiang
China	Liaoyuan Traditional Chinese Medical Hospital	Liaoyuan	Jilin
China	Fenyang Hospital of Shanxi Province	Luliang	Shanxi
China	The Second Chinese Medical Hospital of Luoyang City	Luoyang	Henan
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Nanjing Hospital of T.C.M.	Nanjing	Jiangsu
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Nanshi Hospital of Nanyang	Nanyang	Henan
China	Nanyang T.C.M. Hospital	Nanyang	Henan
China	Panjin Central Hospital	Panjin	Liaoning
China	People's Liberation Army No.202 Hospital	Shenyang	Liaoning
China	People's Liberation Army No.463 Hospital	Shenyang	Liaoning
China	The General Hospital of Shenyang Military	Shenyang	Liaoning
China	The Second People's Hospital of Shenzhen	Shenzhen	Guangdong
China	The Second Affiliated Hospital to Shanxi Medical University	Taiyuan	Shanxi
China	First Teaching Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin
China	Fifth Hospital in Wuhan	Wuhan	Hubei
China	Huangpi District Hospital of T.C.M.	Wuhan	Hubei
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	The Central Hospital of Wuhan	Wuhan	Hubei
China	Tianyou Hospital Affiliated to Wuhan University of Science & Technology	Wuhan	Hubei
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	Zhongshan Hospital of Hubei Province	Wuhan	Hubei
China	Shanxi Province Hospital of T.C.M.	Xi'an	Shanxi
China	Shanxi Provincial People's Hospital	Xi'an	Shanxi
China	The PLA Fourth Fifty-one Hospital	Xi'an	Shanxi
China	Affiliated Hospital of Shanxi University of Chinese Medicine	Xianyang	Shanxi
China	The Second Affiliated Hospital of Shanxi University of T.C.M.	Xianyang	Shanxi
China	People's Hospital of Zhengzhou	Zhengzhou	Henan
China	The First Affiliated Hospital of Henan University of T.C.M.	Zhengzhou	Henan
China	Zhengzhou NO.7 People's Hospital	Zhengzhou	Henan
China	Zhoukou Hospital of T.C.M.	Zhoukou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	China Food and Drug Administration

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The changes on the profiles of micro-RNA in 96 patients selected from certain centers		Day 0, Day 14, Day 90
Other	The changes on the expression profiles of mRNA in 96 patients selected from certain centers		Day 0, Day 14, Day 90
Primary	Modified Rankin Scale 0-1 (favourable outcome) at Day 90		Day 90
Secondary	The Score of effect on symptoms of "Xueyue Zheng"(Blood Stasis syndrome)		Day 0, Day7, Day 14, Day 30, Day 60, Day 90
Secondary	Barthel Index score =90		Day 0, Day7, Day 14, Day 30, Day 60, Day 90
Secondary	NIH stroke scale(NIHSS)	The improvement of the NIHSS score =4 or the NIHSS score of 0 to 1	Day 0, Day7, Day 14, Day 30, Day 60, Day 90
Secondary	EQ-5D scale		Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
Secondary	Global disability on mRS at Day 90.	The proportion of patients with mRS =3 at Day 90.	Day 90
Secondary	Incidence of new-onset major vascular events in 90 days	Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.	Day 90
Secondary	Overall mortality at day 90		Day 90
Secondary	Incidence of severe hemorrhages in 90 days	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.	Day 90
Secondary	Incidence of moderate hemorrhages in 90 days	The definition of "moderate hemorrhages" is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise.	Day 90
Secondary	Documentation of adverse events (AEs) and serious AEs		90 days