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Xingnaojing for Moderate-to-severe Acute Ischemic Stroke (XMAS) (XMAS)

Primary Purpose

Acute Ischemic Stroke

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Xingnaojing injection
Standard care
Sponsored by
Dongzhimen Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Acute Ischemic Stroke, Xingnaojing injection, Randomized Controlled Trial, Traditional Chinese Medicine

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dongzhimen Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Xingnaojing and standard care

Standard care only

Arm Description

Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.

Subjects will receive guidelines-based standard care only.

Outcomes

Primary Outcome Measures

Proportion of patients independent
Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.

Secondary Outcome Measures

Comparison of the change in the NIHSS scores from baseline to 10 days in the two groups.
The NIHSS score ranges from 0 (best score) to 42 (worst score).
Activities of daily living
Activities of daily living measured by Barthel Index score at 30 days and 90 days.
Patient reported outcome (PRO) scale of stroke
Patient reported outcome (PRO) scale of stroke at 10 days.
Early neurologic deterioration (END)
Early neurologic deterioration is defined as an increase of 3 points or more in the NIHSS score between baseline and 48 hours.
Symptomatic Intracranial Hemorrhage (sICH)
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.)
Deaths from any cause
Number of deaths from any cause within 10 days and 90 days after symptom onset.
Safety end points - Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis).
Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis).
Cardiovascular events
Number of patients with recurrence of stroke or myocardial infarction.

Full Information

First Posted
March 28, 2016
Last Updated
October 2, 2019
Sponsor
Dongzhimen Hospital, Beijing
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, The 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
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1. Study Identification

Unique Protocol Identification Number
NCT02728180
Brief Title
Xingnaojing for Moderate-to-severe Acute Ischemic Stroke (XMAS)
Acronym
XMAS
Official Title
Xingnaojing for Moderate-to-severe Acute Ischemic Stroke (XMAS): A Multicenter, Prospective, Randomized, Open-label, Blinded Endpoint Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dongzhimen Hospital, Beijing
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, The 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Acute Ischemic Stroke, Xingnaojing injection, Randomized Controlled Trial, Traditional Chinese Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xingnaojing and standard care
Arm Type
Experimental
Arm Description
Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
Arm Title
Standard care only
Arm Type
Active Comparator
Arm Description
Subjects will receive guidelines-based standard care only.
Intervention Type
Drug
Intervention Name(s)
Xingnaojing injection
Intervention Description
Xingnaojing injection (20 ml), IV (in the vein), every 12 hours for 10 days.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Guidelines-based standard care for acute ischemic stroke.
Primary Outcome Measure Information:
Title
Proportion of patients independent
Description
Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Comparison of the change in the NIHSS scores from baseline to 10 days in the two groups.
Description
The NIHSS score ranges from 0 (best score) to 42 (worst score).
Time Frame
Baseline and 10 days.
Title
Activities of daily living
Description
Activities of daily living measured by Barthel Index score at 30 days and 90 days.
Time Frame
30 days and 90 days
Title
Patient reported outcome (PRO) scale of stroke
Description
Patient reported outcome (PRO) scale of stroke at 10 days.
Time Frame
10 days
Title
Early neurologic deterioration (END)
Description
Early neurologic deterioration is defined as an increase of 3 points or more in the NIHSS score between baseline and 48 hours.
Time Frame
Baseline and 48 hours
Title
Symptomatic Intracranial Hemorrhage (sICH)
Description
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.)
Time Frame
10 dyas
Title
Deaths from any cause
Description
Number of deaths from any cause within 10 days and 90 days after symptom onset.
Time Frame
10 days, 90 days
Title
Safety end points - Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis).
Description
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
Title
Cardiovascular events
Description
Number of patients with recurrence of stroke or myocardial infarction.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Gao, MD
Organizational Affiliation
Dongzhimen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongzhimen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100700
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29037226
Citation
Lai X, Cao K, Kong L, Liu Q, Gao Y; XMAS study investigators. Xingnaojing for Moderate-to-severe Acute ischemic Stroke (XMAS): study protocol for a randomized controlled trial. Trials. 2017 Oct 16;18(1):479. doi: 10.1186/s13063-017-2222-y.
Results Reference
background

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Xingnaojing for Moderate-to-severe Acute Ischemic Stroke (XMAS)

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