Xingnaojing for Moderate-to-severe Acute Ischemic Stroke (XMAS): A Multicenter, Prospective, Randomized, Open-label, Blinded Endpoint Clinical Trial.
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 720
- Locations
- 1
- Primary Endpoint
- Proportion of patients independent
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Acute ischemic stroke within 24 hours of symptom onset.
- •National Institutes of Health Stroke Scale score ≥ 5 and ≤
- •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.
Arms & Interventions
Xingnaojing and standard care
Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
Intervention: Xingnaojing injection (Drug)
Xingnaojing and standard care
Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
Intervention: Standard care (Other)
Standard care only
Subjects will receive guidelines-based standard care only.
Intervention: Standard care (Other)
Outcomes
Primary Outcomes
Proportion of patients independent
Time Frame: 90 days
Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.
Secondary Outcomes
- Patient reported outcome (PRO) scale of stroke(10 days)
- Activities of daily living(30 days and 90 days)
- Deaths from any cause(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).(10 days)
- Comparison of the change in the NIHSS scores from baseline to 10 days in the two groups.(Baseline and 10 days.)
- Early neurologic deterioration (END)(Baseline and 48 hours)
- Symptomatic Intracranial Hemorrhage (sICH)(10 dyas)
- Cardiovascular events(90 days)
Investigators
Ying Gao
Vice president of Dongzhimen Hospital
Dongzhimen Hospital, Beijing