Acute Ischemic Stroke
Conditions
Keywords
Acute Ischemic Stroke, Xingnaojing injection, Randomized Controlled Trial, Traditional Chinese Medicine
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.
Interventions
Xingnaojing injection (20 ml), IV (in the vein), every 12 hours for 10 days.
OTHERStandard care
Guidelines-based standard care for acute ischemic stroke.
Sponsors
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
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
Dongzhimen Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients independent | 90 days | Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activities of daily living | 30 days and 90 days | Activities of daily living measured by Barthel Index score at 30 days and 90 days. |
| Patient reported outcome (PRO) scale of stroke | 10 days | Patient reported outcome (PRO) scale of stroke at 10 days. |
| Early neurologic deterioration (END) | Baseline and 48 hours | Early neurologic deterioration is defined as an increase of 3 points or more in the NIHSS score between baseline and 48 hours. |
| Comparison of the change in the NIHSS scores from baseline to 10 days in the two groups. | Baseline and 10 days. | The NIHSS score ranges from 0 (best score) to 42 (worst score). |
| Deaths from any cause | 10 days, 90 days | 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). | 10 days | Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis). |
| Cardiovascular events | 90 days | Number of patients with recurrence of stroke or myocardial infarction. |
| Symptomatic Intracranial Hemorrhage (sICH) | 10 dyas | 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.) |
Countries
China
Outcome results
None listed