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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
720
Xingnaojing injection (20 ml), IV (in the vein), every 12 hours for 10 days.
Guidelines-based standard care for acute ischemic stroke.
Dongzhimen Hospital
Beijing, Beijing Municipality, China
Proportion of patients independent
Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.
Time frame: 90 days
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.
Activities of daily living
Activities of daily living measured by Barthel Index score at 30 days and 90 days.
Time frame: 30 days and 90 days
Patient reported outcome (PRO) scale of stroke
Patient reported outcome (PRO) scale of stroke at 10 days.
Time frame: 10 days
Early neurologic deterioration (END)
Early neurologic deterioration is defined as an increase of 3 points or more in the NIHSS score between baseline and 48 hours.
Time frame: Baseline and 48 hours
Symptomatic Intracranial Hemorrhage (sICH)
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.)
Time frame: 10 dyas
Deaths from any cause
Number of deaths from any cause within 10 days and 90 days after symptom onset.
Time frame: 10 days, 90 days
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Safety end points - Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis).
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
Cardiovascular events
Number of patients with recurrence of stroke or myocardial infarction.
Time frame: 90 days