Acute Ischemic StrokePhase 4XMASNCT02728180
Xingnaojing for Moderate-to-severe Acute Ischemic Stroke (XMAS)
A Phase 4 study testing Xingnaojing injection in people with Acute Ischemic Stroke, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Xingnaojing injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to 31 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- Other conditions that render outcomes or follow-up unlikely to be assessed..
- Known to be pregnant or breastfeeding.
- Currently receiving an investigational drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Xingnaojing injection, Standard care
- Keywords
- Acute Ischemic Stroke, Xingnaojing injection, Randomized Controlled Trial, Traditional Chinese Medicine
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xingnaojing injectionDrug
Xingnaojing injection (20 ml), IV (in the vein), every 12 hours for 10 days.
Standard careOther
Guidelines-based standard care for acute ischemic stroke.
| Study group | Role | What they receive |
|---|---|---|
| Xingnaojing and standard care | Experimental | Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care. Receives: Drug: Xingnaojing injection; Other: Standard care |
| Standard care only | Active comparator | Subjects will receive guidelines-based standard care only. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients independent
Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.
Measured: 90 days
Secondary outcomes (8)
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).
Measured: Baseline and 10 days.
Activities of daily living
Activities of daily living measured by Barthel Index score at 30 days and 90 days.
Measured: 30 days and 90 days
Patient reported outcome (PRO) scale of stroke
Patient reported outcome (PRO) scale of stroke at 10 days.
Measured: 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.
Measured: 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.)
Measured: 10 dyas
Deaths from any cause
Number of deaths from any cause within 10 days and 90 days after symptom onset.
Measured: 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).
Measured: 10 days
Cardiovascular events
Number of patients with recurrence of stroke or myocardial infarction.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startMar 2016
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Beijing Chao Yang Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine, Beijing Emergency Medical Center, Chengdu University of Traditional Chinese Medicine, Deyang People's Hospital, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, The Second Hospital of Hebei Medical University, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Hunan Academy of Chinese Medicine, The First Hospital of Jilin University, China-Japan Union Hospital, Jilin University, Jiangmen Wuyi Hospital of Traditional Chinese Medicine, Jiangxi Provincial People's Hopital, Mianyang Central Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Shandong University of Traditional Chinese Medicine, Shaanxi Provincial People's Hospital, Shaanxi Hospital of Traditional Chinese Medicine, Tianshui Hospital of Traditional Chinese Medicine, Wuxi Hospital of Traditional Chinese Medicine, The First Hospital of Wuhan, Zhejiang Provincial Tongde Hospital, Zhejiang Provincial Hospital of TCM, Zhongshan Hospital Of Traditional Chinese Medicine, The Fifth People Hospital of Chongqing, Chongqing Traditional Chinese Medicine Hospital, Zibo Hospital of Traditional Chinese Medicine, Liling Hospital of Traditional Chinese Medicine, Cangzhou Hospital of Integrated Medicine, Yantai Yuhuangding Hospital
- Responsible party
- Principal investigator, Ying Gao, Dongzhimen Hospital, Beijing
- Investigators
- Ying Gao, MD, Principal investigator, Dongzhimen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728180
- Sponsor's protocol ID
- 2014BAI10B05-01
- Acronym
- XMAS
- Status last verified
- Oct 2019
- First submitted
- 28 Mar 2016
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lai X, Cao K, Kong L, Liu Q, Gao Y; XMAS study investigators. Xingnaojing for Moderate-to-severe Acute ischemic Stroke (XMAS): study protocol for a randomized controlled trial. Trials. 2017 Oct 16;18(1):479. doi: 10.1186/s13063-017-2222-y.
PubMed 29037226
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xingnaojing for Moderate-to-severe Acute Ischemic Stroke (XMAS): A Multicenter, Prospective, Randomized, Open-label, Blinded Endpoint Clinical Trial.
- ClinicalTrials.gov ID
- NCT02728180
- Acronym / sponsor ID
- XMAS / 2014BAI10B05-01
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Xingnaojing injection, Randomized Controlled Trial, Traditional Chinese Medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Beijing Chao Yang Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine, Beijing Emergency Medical Center, Chengdu University of Traditional Chinese Medicine, Deyang People's Hospital, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, The Second Hospital of Hebei Medical University, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Hunan Academy of Chinese Medicine, The First Hospital of Jilin University, China-Japan Union Hospital, Jilin University, Jiangmen Wuyi Hospital of Traditional Chinese Medicine, Jiangxi Provincial People's Hopital, Mianyang Central Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Shandong University of Traditional Chinese Medicine, Shaanxi Provincial People's Hospital, Shaanxi Hospital of Traditional Chinese Medicine, Tianshui Hospital of Traditional Chinese Medicine, Wuxi Hospital of Traditional Chinese Medicine, The First Hospital of Wuhan, Zhejiang Provincial Tongde Hospital, Zhejiang Provincial Hospital of TCM, Zhongshan Hospital Of Traditional Chinese Medicine, The Fifth People Hospital of Chongqing, Chongqing Traditional Chinese Medicine Hospital, Zibo Hospital of Traditional Chinese Medicine, Liling Hospital of Traditional Chinese Medicine, Cangzhou Hospital of Integrated Medicine, Yantai Yuhuangding Hospital
- Study start
- Mar 2016
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xingnaojing and standard care | Experimental | Drug: Xingnaojing injection, Other: Standard careSubjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care. |
| Standard care only | Active comparator | Other: Standard careSubjects will receive guidelines-based standard care only. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xingnaojing injectionXingnaojing injection (20 ml), IV (in the vein), every 12 hours for 10 days. | Drug | Xingnaojing and standard care |
| Standard careGuidelines-based standard care for acute ischemic stroke. | Other | Standard care only, Xingnaojing and standard care |
Primary outcome
Proportion of patients independent
Time frame: 90 days
Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.
8 secondary outcomes
Comparison of the change in the NIHSS scores from baseline to 10 days in the two groups.
Time frame: Baseline and 10 days.
Activities of daily living
Time frame: 30 days and 90 days
Patient reported outcome (PRO) scale of stroke
Time frame: 10 days
Early neurologic deterioration (END)
Time frame: Baseline and 48 hours
Symptomatic Intracranial Hemorrhage (sICH)
Time frame: 10 dyas
Deaths from any cause
Time frame: 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).
Time frame: 10 days
Cardiovascular events
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Background: PubMed 29037226Lai X, Cao K, Kong L, Liu Q, Gao Y; XMAS study investigators. Xingnaojing for Moderate-to-severe Acute ischemic Stroke (XMAS): study protocol for a randomized controlled trial. Trials. 2017 Oct 16;18(1):479. doi: 10.1186/s13063-017-2222-y.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Gao, MD principal investigator
Dongzhimen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xingnaojing injection in people with Acute Ischemic Stroke, run by Dongzhimen Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients independent (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02728180, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.