Clinical trial NCT04150835: Xingnaojing for Mild-to-severe Acute Ischemic Stroke
Official title: Xingnaojing for Mild-to-severe Acute Ischemic Stroke (XMAS-2): A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Ischemic Stroke
Stroke, Acute
Stroke, Ischemic
Keywords: Acute ischemic stroke
Xingnaojing injection
Traditional Chinese Medicine
Double-Blind
Randomized Controlled Trial
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
name: Beijing Shuyi Hospital
name: The Airport Hospital of Shunyi District Beijing
name: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
name: The NO.4 People's Hospital of Hengshui
name: The Second Hospital of Hebei Medical University
name: The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: The Affiliated Hospital of Shaanxi University of Chinese Medicine
name: Tianshui Hospital of Traditional Chinese Medicine
name: The Affiliated Hospital of Changzhi Academy of TCM
name: Zibo Hospital of Traditional Chinese Medicine
name: Yantai Yuhuangding Hospital
name: Shandong University of Traditional Chinese Medicine
name: Zhejiang Provincial Hospital of TCM
name: Zhejiang Provincial Tongde Hospital
name: Second Affiliated Hospital of Wenzhou Medical University
name: People's Hospital of Quzhou
name: Longhua Hospital
name: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
name: Taizhou Hospital of Traditional Chinese Medicine
name: The First Affiliated Hospital of Guizhou University of TCM
name: Guangzhou Hospital of Traditional Chinese Medicine
name: The First Affiliated Hospital of Guangxi University of Chinese Medicine
name: Liling Hospital of Traditional Chinese Medicine
name: Hunan Academy of Traditional Chinese Medicine Affiliated Hospital
name: Hubei Hospital of Traditional Chinese Medicine
name: The First Hospital of Jilin University
name: Anshan Central Hospital
name: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: The First Hospital of Qiqihar City
name: Haikou People's Hospital
name: The Second People's Hospital of Anhui Province
name: The Third Affiliated Hospital of Shenzhen University
name: The Third People's Hospital of Hubei Province
name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: The Third Hospital of Xi'an City
First posted: 2019-11-05
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
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 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.

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;

Primary outcomes:
measure: The proportion of patients independent.
timeFrame: 90 days
Secondary outcomes:
measure: Early neurological deterioration.
timeFrame: Baseline and 3 days
measure: Neurological impairment evaluated by National Institute of Health Stroke Scale (NIHSS).
timeFrame: Baseline and 10 days
measure: Patient reported outcome
timeFrame: 10 days
measure: State of consciousness
timeFrame: 48 hours and 7 days
measure: Activities of daily living
timeFrame: 30 days and 90 days
measure: The proportion of patients independent at 30 days.
timeFrame: 30 days
measure: The recurrence rate of cerebrovascular events
timeFrame: Within 90 days
measure: Stroke related deaths and deaths from any cause
timeFrame: Within 10 days and 90 days
measure: Safety end points
timeFrame: 10 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: