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Xingnaojing for Mild-to-severe Acute Ischemic Stroke (XMAS-2)

Primary Purpose

Acute Ischemic Stroke, Stroke, Acute, Stroke, Ischemic

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Xingnaojing injection
Xingnaojing placebo 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, Traditional Chinese Medicine, Double-Blind, Randomized Controlled Trial

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of Acute ischemic stroke；
  • Symptom onset within 24 hours；
  • Age ≥ 18 and ≤ 80 years；
  • NIHSS score ≥ 4 and ≤ 25；
  • Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

  • Planned or already receiving intravenous thrombolysis or endovascular treatment;
  • Suspected secondary stroke caused by tumor, brain trauma, or hematological diseases;
  • Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scale score ≥ 2) ;
  • Other conditions that cause cardiogenic embolism (e.g., atrial fibrillation, rheumatic heart disease, valvular heart disease);
  • 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 (ALT), or aspartate aminotransferase (AST) value that is twice the upper limit of normal);
  • Life expectancy of 3 months 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 HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Xingnaojing

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

The proportion of patients independent.
Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.The Modified Rankin Scale Score ranges from 0 (best score) to 6 (worst score).

Secondary Outcome Measures

Early neurological deterioration.
The early neurologic deterioration is defined as an increase of 1 points or more in the National Institute of Health Stroke Scale (NIHSS) score between baseline and 3 days. The NIHSS score ranges from 0 (best score) to 42 (worst score).
Neurological impairment evaluated by National Institute of Health Stroke Scale (NIHSS).
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).
Patient reported outcome
Patient reported outcome (PRO) scale of stroke at 10 days.The PRO score ranges from 36(best score) to 180 (worst score).
State of consciousness
The state of consciousness evaluated by Glasgow Coma Scale at 7 days. The Glasgow score ranges from 3(worst score) to 15 (best score).
Activities of daily living
Activities of daily living will be measured by Barthel Index score at 30 days and 90 days.The Barthel Index score ranges from 0 (worst score) to 100 (best score).
The proportion of patients independent at 30 days.
The proportion of patients independent will be evaluated by mRS at 30 days.The mRS score ranges from 0 (best score) to 6 (worst score).
The recurrence rate of cerebrovascular events
The recurrence rate of cerebrovascular events within 90 days.
Stroke related deaths and deaths from any cause
Stroke related deaths and 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).

Full Information

First Posted
November 1, 2019
Last Updated
March 29, 2021
Sponsor
Dongzhimen Hospital, Beijing
Collaborators
Peking University Third Hospital, Beijing Shuyi Hospital, The Airport Hospital of Shunyi District Beijing, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, The NO.4 People's Hospital of Hengshui, The Second Hospital of Hebei Medical University, The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine, The Affiliated Hospital of Shaanxi University of Chinese Medicine, Tianshui Hospital of Traditional Chinese Medicine, The Affiliated Hospital of Changzhi Academy of TCM, Zibo Hospital of Traditional Chinese Medicine, Yantai Yuhuangding Hospital, Shandong University of Traditional Chinese Medicine, Zhejiang Provincial Hospital of TCM, Zhejiang Provincial Tongde Hospital, Second Affiliated Hospital of Wenzhou Medical University, People's Hospital of Quzhou, Longhua Hospital, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Taizhou Traditional Chinese Medicine Hospital, The First Affiliated Hospital of Guizhou University of TCM, Guangzhou Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Guangxi University of Chinese Medicine, Liling Hospital of Traditional Chinese Medicine, Hunan Academy of Traditional Chinese Medicine Affiliated Hospital, Hubei Hospital of Traditional Chinese Medicine, The First Hospital of Jilin University, Anshan Central Hospital, First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, The First Hospital of Qiqihar City, Haikou People's Hospital, The Second People's Hospital of Anhui Province, The Third Affiliated Hospital of Shenzhen University, The Third People's Hospital of Hubei Province, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, The Third Hospital of Xi'an City
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1. Study Identification

Unique Protocol Identification Number
NCT04150835
Brief Title
Xingnaojing for Mild-to-severe Acute Ischemic Stroke
Acronym
XMAS-2
Official Title
Xingnaojing for Mild-to-severe Acute Ischemic Stroke (XMAS-2): A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 19, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dongzhimen Hospital, Beijing
Collaborators
Peking University Third Hospital, Beijing Shuyi Hospital, The Airport Hospital of Shunyi District Beijing, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, The NO.4 People's Hospital of Hengshui, The Second Hospital of Hebei Medical University, The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine, The Affiliated Hospital of Shaanxi University of Chinese Medicine, Tianshui Hospital of Traditional Chinese Medicine, The Affiliated Hospital of Changzhi Academy of TCM, Zibo Hospital of Traditional Chinese Medicine, Yantai Yuhuangding Hospital, Shandong University of Traditional Chinese Medicine, Zhejiang Provincial Hospital of TCM, Zhejiang Provincial Tongde Hospital, Second Affiliated Hospital of Wenzhou Medical University, People's Hospital of Quzhou, Longhua Hospital, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Taizhou Traditional Chinese Medicine Hospital, The First Affiliated Hospital of Guizhou University of TCM, Guangzhou Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Guangxi University of Chinese Medicine, Liling Hospital of Traditional Chinese Medicine, Hunan Academy of Traditional Chinese Medicine Affiliated Hospital, Hubei Hospital of Traditional Chinese Medicine, The First Hospital of Jilin University, Anshan Central Hospital, First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, The First Hospital of Qiqihar City, Haikou People's Hospital, The Second People's Hospital of Anhui Province, The Third Affiliated Hospital of Shenzhen University, The Third People's Hospital of Hubei Province, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, The Third Hospital of Xi'an City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
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 daily living ability of acute ischemic stroke at 90 days.
Detailed Description
The XMAS-2 study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary hypothesis of this trial is that Xingnaojing will improve the daily living ability of acute ischemic stroke at 90 days. Xingnaojing will be compared to placebo, combined with guidelines-based standard care in patients with acute ischemic stroke within 24 hours of symptom onset. All participants will have a National Institutes of Health Stroke Scale(NIHSS)entry score of 4-25. Participants who have planned or already received the intravenous thrombolysis or endovascular treatment will be excluded. The primary outcome will be determined at 90 days.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xingnaojing
Arm Type
Experimental
Arm Description
Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive intravenously administered Xingnaojing placebo, combined with guidelines-based standard care.
Intervention Type
Drug
Intervention Name(s)
Xingnaojing injection
Intervention Description
Xingnaojing injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days.
Intervention Type
Drug
Intervention Name(s)
Xingnaojing placebo injection
Intervention Description
Xingnaojing placebo injection (20 ml)+0.9% diluted sodium chloride injection 250ml, 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
The proportion of patients independent.
Description
Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.The Modified Rankin Scale Score ranges from 0 (best score) to 6 (worst score).
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Early neurological deterioration.
Description
The early neurologic deterioration is defined as an increase of 1 points or more in the National Institute of Health Stroke Scale (NIHSS) score between baseline and 3 days. The NIHSS score ranges from 0 (best score) to 42 (worst score).
Time Frame
Baseline and 3 days
Title
Neurological impairment evaluated by National Institute of Health Stroke Scale (NIHSS).
Description
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).
Time Frame
Baseline and 10 days
Title
Patient reported outcome
Description
Patient reported outcome (PRO) scale of stroke at 10 days.The PRO score ranges from 36(best score) to 180 (worst score).
Time Frame
10 days
Title
State of consciousness
Description
The state of consciousness evaluated by Glasgow Coma Scale at 7 days. The Glasgow score ranges from 3(worst score) to 15 (best score).
Time Frame
48 hours and 7 days
Title
Activities of daily living
Description
Activities of daily living will be measured by Barthel Index score at 30 days and 90 days.The Barthel Index score ranges from 0 (worst score) to 100 (best score).
Time Frame
30 days and 90 days
Title
The proportion of patients independent at 30 days.
Description
The proportion of patients independent will be evaluated by mRS at 30 days.The mRS score ranges from 0 (best score) to 6 (worst score).
Time Frame
30 days
Title
The recurrence rate of cerebrovascular events
Description
The recurrence rate of cerebrovascular events within 90 days.
Time Frame
Within 90 days
Title
Stroke related deaths and deaths from any cause
Description
Stroke related deaths and deaths from any cause within 10 days and 90 days after symptom onset.
Time Frame
Within 10 days and 90 days
Title
Safety end points
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Acute ischemic stroke； Symptom onset within 24 hours； Age ≥ 18 and ≤ 80 years； NIHSS score ≥ 4 and ≤ 25； Patient or legally authorized representative has signed informed consent. Exclusion Criteria: Planned or already receiving intravenous thrombolysis or endovascular treatment; Suspected secondary stroke caused by tumor, brain trauma, or hematological diseases; Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scale score ≥ 2) ; Other conditions that cause cardiogenic embolism (e.g., atrial fibrillation, rheumatic heart disease, valvular heart disease); 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 (ALT), or aspartate aminotransferase (AST) value that is twice the upper limit of normal); Life expectancy of 3 months 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Gao, MD
Phone
0086-010-84013209
Email
gaoying973@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tiantian Meng, MD
Phone
(+86)17812171713
Email
17812171713@163.com
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Gao, MD
Phone
0086-010-84013209
Email
gaoying973@126.com
First Name & Middle Initial & Last Name & Degree
Tiantian Meng, MD
Phone
0086-17812171713
Email
17812171713@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Xingnaojing for Mild-to-severe Acute Ischemic Stroke

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