Xingnaojing for Moderate-to-severe Acute Ischemic Stroke (XMAS)
- Registration Number
- NCT02728180
- Lead Sponsor
- Dongzhimen Hospital, Beijing
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 720
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Xingnaojing and standard care Standard care Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care. Standard care only Standard care Subjects will receive guidelines-based standard care only. Xingnaojing and standard care Xingnaojing injection Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
- Primary Outcome Measures
Name Time Method Proportion of patients independent 90 days Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.
- Secondary Outcome Measures
Name Time Method Patient reported outcome (PRO) scale of stroke 10 days Patient reported outcome (PRO) scale of stroke at 10 days.
Activities of daily living 30 days and 90 days Activities of daily living measured by Barthel Index score at 30 days and 90 days.
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).
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).
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.
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.)
Cardiovascular events 90 days Number of patients with recurrence of stroke or myocardial infarction.
Trial Locations
- Locations (1)
Dongzhimen Hospital
🇨🇳Beijing, Beijing, China