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

Xingnaojing for Moderate-to-severe Acute Ischemic Stroke (XMAS): A Multicenter, Prospective, Randomized, Open-label, Blinded Endpoint Clinical Trial.

Sponsors

Lead Sponsor: Dongzhimen Hospital, Beijing

Collaborator: 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

Source 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.

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.

Overall Status Active, not recruiting
Start Date 2016-03-01
Completion Date 2019-12-31
Primary Completion Date 2019-12-31
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Proportion of patients independent 90 days
Secondary Outcome
Measure Time Frame
Comparison of the change in the NIHSS scores from baseline to 10 days in the two groups. Baseline and 10 days.
Activities of daily living 30 days and 90 days
Patient reported outcome (PRO) scale of stroke 10 days
Early neurologic deterioration (END) Baseline and 48 hours
Symptomatic Intracranial Hemorrhage (sICH) 10 dyas
Deaths from any cause 10 days, 90 days
Safety end points - Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis). 10 days
Cardiovascular events 90 days
Enrollment 720
Condition
Intervention

Intervention Type: Drug

Intervention Name: Xingnaojing injection

Description: Xingnaojing injection (20 ml), IV (in the vein), every 12 hours for 10 days.

Arm Group Label: Xingnaojing and standard care

Intervention Type: Other

Intervention Name: Standard care

Description: Guidelines-based standard care for acute ischemic stroke.

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.

Gender:

All

Minimum Age:

35 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Ying Gao, MD Principal Investigator Dongzhimen Hospital
Location
Facility: Dongzhimen Hospital
Location Countries

China

Verification Date

2019-10-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Dongzhimen Hospital, Beijing

Investigator Full Name: Ying Gao

Investigator Title: Vice president of Dongzhimen Hospital

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Xingnaojing and standard care

Type: Experimental

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

Label: Standard care only

Type: Active Comparator

Description: Subjects will receive guidelines-based standard care only.

Acronym XMAS
Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

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