Clinical trial NCT02728180: Xingnaojing for Moderate-to-severe Acute Ischemic Stroke (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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Ischemic Stroke
Keywords: Acute Ischemic Stroke
Xingnaojing injection
Randomized Controlled Trial
Traditional Chinese Medicine
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Beijing Chao Yang Hospital
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Beijing Emergency Medical Center
name: The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
name: Deyang People's Hospital
name: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
name: The Second Hospital of Hebei Medical University
name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Hunan Academy of Chinese Medicine
name: The First Hospital of Jilin University
name: China-Japan Union Hospital, Jilin University
name: Jiangmen Wuyi Hospital of Traditional Chinese Medicine
name: Jiangxi Provincial People's Hopital
name: Mianyang Central Hospital
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Shandong University of Traditional Chinese Medicine
name: Shaanxi Provincial People's Hospital
name: Shaanxi Provincial Hospital of Traditional Chinese Medicine
name: The Affiliated Hospital of Shaanxi University of Chinese Medicine
name: Tianshui Hospital of Traditional Chinese Medicine
name: Wuxi Hospital of Traditional Chinese Medicine
name: The First Hospital of Wuhan
name: Zhejiang Provincial Tongde Hospital
name: Zhejiang Provincial Hospital of TCM
name: Zhongshan Hospital Of Traditional Chinese Medicine
name: The Fifth People Hospital of Chongqing
name: Chongqing Traditional Chinese Medicine Hospital
name: Zibo Hospital of Traditional Chinese Medicine
name: Liling Hospital of Traditional Chinese Medicine
name: Cangzhou Hospital of Integrated Medicine
name: Yantai Yuhuangding Hospital
First posted: 2016-04-05
Enrollment: 720
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of patients independent
timeFrame: 90 days
Secondary outcomes:
measure: Comparison of the change in the NIHSS scores from baseline to 10 days in the two groups.
timeFrame: Baseline and 10 days.
measure: Activities of daily living
timeFrame: 30 days and 90 days
measure: Patient reported outcome (PRO) scale of stroke
timeFrame: 10 days
measure: Early neurologic deterioration (END)
timeFrame: Baseline and 48 hours
measure: Symptomatic Intracranial Hemorrhage (sICH)
timeFrame: 10 dyas
measure: Deaths from any cause
timeFrame: 10 days, 90 days
measure: Safety end points - Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis).
timeFrame: 10 days
measure: Cardiovascular events
timeFrame: 90 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital
state: Beijing
Study officials:
affiliation: Dongzhimen Hospital
name: Ying Gao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.