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Trial record 1 of 1 for:    NCT02728180
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Xingnaojing for Moderate-to-severe Acute Ischemic Stroke (XMAS) (XMAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02728180
Recruitment Status : Active, not recruiting
First Posted : April 5, 2016
Last Update Posted : October 4, 2019
Sponsor:
Collaborators:
Beijing Tiantan Hospital
Beijing Chao Yang Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
Beijing Emergency Medical Center
The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Deyang People's Hospital
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
The Second Hospital of Hebei Medical University
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Hunan Academy of Chinese Medicine
First Hospital of Jilin University
China-Japan Union Hospital, Jilin University
Jiangmen Wuyi Hospital of Traditional Chinese Medicine
Jiangxi Provincial People's Hopital
Mianyang Central Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Shandong University of Traditional Chinese Medicine
Shaanxi Provincial People's Hospital
Shaanxi Provincial Hospital of Traditional Chinese Medicine
The Affiliated Hospital of Shaanxi University of Chinese Medicine
Tianshui Hospital of Traditional Chinese Medicine
Wuxi Hospital of Traditional Chinese Medicine
The First Hospital of Wuhan
Zhejiang Provincial Tongde Hospital
Zhejiang Provincial Hospital of TCM
Zhongshan Hospital Of Traditional Chinese Medicine
The Fifth People Hospital of Chongqing
Chongqing Traditional Chinese Medicine Hospital
Zibo Hospital of Traditional Chinese Medicine
Liling Hospital of Traditional Chinese Medicine
Cangzhou Hospital of Integrated Medicine
Yantai Yuhuangding Hospital
Information provided by (Responsible Party):
Ying Gao, Dongzhimen Hospital, Beijing

Brief Summary:
The main purpose of this trial is to determine whether Xingnaojing, intravenously administered within 24 hours of symptom onset, improves the 3-month outcome in participants with acute ischemic stroke.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: Xingnaojing injection Other: Standard care Phase 4

Detailed Description:
Xingnaojing is widely used in China, but there is lack of high-quality evidence of its efficacy for acute ischemic stroke currently. The primary hypothesis of this trial is that Xingnaojing will increase the proportion of people alive and independent at three months. Xingnaojing, combined with guidelines-based standard care, will be compared to standard care alone in patients with acute ischemic stroke within 24 hours of symptom onset. All patients will have a National Institutes of Health Stroke Scale (NIHSS) entry score of 5-20. Patients in each group will be treated according to the guidelines-based standard care, including intravenous thrombolysis if appropriate. The primary outcome will be determined at 3 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Xingnaojing for Moderate-to-severe Acute Ischemic Stroke (XMAS): A Multicenter, Prospective, Randomized, Open-label, Blinded Endpoint Clinical Trial.
Study Start Date : March 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Xingnaojing and standard care
Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
Drug: Xingnaojing injection
Xingnaojing injection (20 ml), IV (in the vein), every 12 hours for 10 days.

Other: Standard care
Guidelines-based standard care for acute ischemic stroke.

Active Comparator: Standard care only
Subjects will receive guidelines-based standard care only.
Other: Standard care
Guidelines-based standard care for acute ischemic stroke.




Primary Outcome Measures :
  1. Proportion of patients independent [ Time Frame: 90 days ]
    Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.


Secondary Outcome Measures :
  1. Comparison of the change in the NIHSS scores from baseline to 10 days in the two groups. [ Time Frame: Baseline and 10 days. ]
    The NIHSS score ranges from 0 (best score) to 42 (worst score).

  2. Activities of daily living [ Time Frame: 30 days and 90 days ]
    Activities of daily living measured by Barthel Index score at 30 days and 90 days.

  3. Patient reported outcome (PRO) scale of stroke [ Time Frame: 10 days ]
    Patient reported outcome (PRO) scale of stroke at 10 days.

  4. Early neurologic deterioration (END) [ Time Frame: Baseline and 48 hours ]
    Early neurologic deterioration is defined as an increase of 3 points or more in the NIHSS score between baseline and 48 hours.

  5. Symptomatic Intracranial Hemorrhage (sICH) [ Time Frame: 10 dyas ]
    Symptomatic Intracranial Hemorrhage (sICH) within 10 days of stroke onset. (Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH.)

  6. Deaths from any cause [ Time Frame: 10 days, 90 days ]
    Number of deaths from any cause within 10 days and 90 days after symptom onset.

  7. Safety end points - Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis). [ Time Frame: 10 days ]
    Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis).

  8. Cardiovascular events [ Time Frame: 90 days ]
    Number of patients with recurrence of stroke or myocardial infarction.



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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute ischemic stroke within 24 hours of symptom onset.
  • National Institutes of Health Stroke Scale score ≥ 5 and ≤ 20.
  • Age ≥ 35 and ≤ 80 years.
  • Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

  • Planned or already received endovascular treatment.
  • Suspected secondary stroke caused by tumor, brain trauma, or hematologic diseases.
  • Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scare score ≥2 ).
  • Other conditions that lead to motor dysfunction (e.g. severe osteoarthrosis, rheumatoid arthritis).
  • Significant renal or hepatic insufficiency (defined as a serum creatinine concentration, alanine aminotransferase, or aspartate aminotransferase value that is twice greater than the upper limit of normal).
  • Life expectancy of 90 days or less due to other life threatening illness (e.g. advanced cancer).
  • Other conditions that render outcomes or follow-up unlikely to be assessed..
  • Known to be pregnant or breastfeeding.
  • Currently receiving an investigational drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728180


Locations
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China, Beijing
Dongzhimen Hospital
Beijing, Beijing, China, 100700
Sponsors and Collaborators
Dongzhimen Hospital, Beijing
Beijing Tiantan Hospital
Beijing Chao Yang Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
Beijing Emergency Medical Center
The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Deyang People's Hospital
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
The Second Hospital of Hebei Medical University
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Hunan Academy of Chinese Medicine
First Hospital of Jilin University
China-Japan Union Hospital, Jilin University
Jiangmen Wuyi Hospital of Traditional Chinese Medicine
Jiangxi Provincial People's Hopital
Mianyang Central Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Shandong University of Traditional Chinese Medicine
Shaanxi Provincial People's Hospital
Shaanxi Provincial Hospital of Traditional Chinese Medicine
The Affiliated Hospital of Shaanxi University of Chinese Medicine
Tianshui Hospital of Traditional Chinese Medicine
Wuxi Hospital of Traditional Chinese Medicine
The First Hospital of Wuhan
Zhejiang Provincial Tongde Hospital
Zhejiang Provincial Hospital of TCM
Zhongshan Hospital Of Traditional Chinese Medicine
The Fifth People Hospital of Chongqing
Chongqing Traditional Chinese Medicine Hospital
Zibo Hospital of Traditional Chinese Medicine
Liling Hospital of Traditional Chinese Medicine
Cangzhou Hospital of Integrated Medicine
Yantai Yuhuangding Hospital
Investigators
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Principal Investigator: Ying Gao, MD Dongzhimen Hospital
Publications:
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Responsible Party: Ying Gao, Vice president of Dongzhimen Hospital, Dongzhimen Hospital, Beijing
ClinicalTrials.gov Identifier: NCT02728180    
Other Study ID Numbers: 2014BAI10B05-01
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ying Gao, Dongzhimen Hospital, Beijing:
Acute Ischemic Stroke
Xingnaojing injection
Randomized Controlled Trial
Traditional Chinese Medicine
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia