Danhong Injection in the Treatment of Acute Ischemic Stroke

This study is currently recruiting participants.
Verified February 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: February 13, 2014
Last verified: February 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
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

  Show 33 Study Locations
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 affiliated to Capital Medical University
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: February 13, 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 April 14, 2014