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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Drug: Xingnaojing injection
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xingnaojing and standard care<br>Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care. | Drug: Xingnaojing injection<br>* Xingnaojing injection (20 ml), IV (in the vein), every 12 hours for 10 days.<br>Other: Standard care<br>* Guidelines-based standard care for acute ischemic stroke.<br>|
| Active Comparator: Standard care only<br>Subjects will receive guidelines-based standard care only. | Other: Standard care<br>* Guidelines-based standard care for acute ischemic stroke.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients independent | Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline and 10 days. | 
| Activities of daily living | Activities of daily living measured by Barthel Index score at 30 days and 90 days. | 30 days and 90 days | 
| Patient reported outcome (PRO) scale of stroke | Patient reported outcome (PRO) scale of stroke at 10 days. | 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. | 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.) | 10 dyas | 
| Deaths from any cause | Number of deaths from any cause within 10 days and 90 days after symptom onset. | 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). | 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 | Number of patients with recurrence of stroke or myocardial infarction. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Ischemic Stroke, Xingnaojing injection, Randomized Controlled Trial, Traditional Chinese Medicine