- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02728180
Xingnaojing for Moderate-to-severe Acute Ischemic Stroke (XMAS) (XMAS)
October 2, 2019 updated by: Ying Gao, Dongzhimen Hospital, Beijing
Xingnaojing for Moderate-to-severe Acute Ischemic Stroke (XMAS): A Multicenter, Prospective, Randomized, Open-label, Blinded Endpoint Clinical Trial.
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
720
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100700
- Dongzhimen Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Xingnaojing and standard care
Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
|
Guidelines-based standard care for acute ischemic stroke.
Xingnaojing injection (20 ml), IV (in the vein), every 12 hours for 10 days.
|
ACTIVE_COMPARATOR: Standard care only
Subjects will receive guidelines-based standard care only.
|
Guidelines-based standard care for acute ischemic stroke.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients independent
Time Frame: 90 days
|
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.
Time Frame: Baseline and 10 days.
|
The NIHSS score ranges from 0 (best score) to 42 (worst score).
|
Baseline and 10 days.
|
Activities of daily living
Time Frame: 30 days and 90 days
|
Activities of daily living measured by Barthel Index score at 30 days and 90 days.
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30 days and 90 days
|
Patient reported outcome (PRO) scale of stroke
Time Frame: 10 days
|
Patient reported outcome (PRO) scale of stroke at 10 days.
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10 days
|
Early neurologic deterioration (END)
Time Frame: 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.
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Baseline and 48 hours
|
Symptomatic Intracranial Hemorrhage (sICH)
Time Frame: 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.)
|
10 dyas
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Deaths from any cause
Time Frame: 10 days, 90 days
|
Number of deaths from any cause within 10 days and 90 days after symptom onset.
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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).
Time Frame: 10 days
|
Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis).
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10 days
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Cardiovascular events
Time Frame: 90 days
|
Number of patients with recurrence of stroke or myocardial infarction.
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90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (ANTICIPATED)
December 31, 2019
Study Completion (ANTICIPATED)
December 31, 2019
Study Registration Dates
First Submitted
March 28, 2016
First Submitted That Met QC Criteria
April 4, 2016
First Posted (ESTIMATE)
April 5, 2016
Study Record Updates
Last Update Posted (ACTUAL)
October 4, 2019
Last Update Submitted That Met QC Criteria
October 2, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014BAI10B05-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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