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
Verified date | June 2022 |
Source | China Academy of Chinese Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether Danhong injection is effective in the treatment of acute ischemic stroke.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
China Academy of Chinese Medical Sciences | China Food and Drug Administration |
China,
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 |
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