Acute Ischemic StrokePhase 4XMAS-2NCT04150835
Xingnaojing for Mild-to-severe Acute Ischemic Stroke
A Phase 4 study testing Xingnaojing injection in people with Acute Ischemic Stroke and Stroke, Acute, 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 daily living ability of acute ischemic stroke at 90 days. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke, Stroke, Acute, Stroke, Ischemic
- What is being tested?
- Xingnaojing injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2020to Dec 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Acute ischemic stroke；
- Symptom onset within 24 hours；
- Age ≥ 18 and ≤ 80 years；
- NIHSS score ≥ 4 and ≤ 25；
- Patient or legally authorized representative has signed informed consent.
Who cannot join
- Planned or already receiving intravenous thrombolysis or endovascular treatment;
- Suspected secondary stroke caused by tumor, brain trauma, or hematological diseases;
- Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scale score ≥ 2) ;
- Other conditions that cause cardiogenic embolism (e.g., atrial fibrillation, rheumatic heart disease, valvular heart disease);
- 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 (ALT), or aspartate aminotransferase (AST) value that is twice the upper limit of normal);
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- Life expectancy of 3 months 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dongzhimen Hospital
Beijing, Beijing Municipality, 100700
Ying Gao, MD, 0086-010-84013209, gaoying973@126.com
Tiantian Meng, MD, 0086-17812171713, 17812171713@163.com
About this study
Official title: Xingnaojing for Mild-to-severe Acute Ischemic Stroke (XMAS-2): A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial
The main purpose of this trial is to determine whether Xingnaojing, intravenously administered within 24 hours of symptom onset, improves the daily living ability of acute ischemic stroke at 90 days.
Read the detailed description
The XMAS-2 study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary hypothesis of this trial is that Xingnaojing will improve the daily living ability of acute ischemic stroke at 90 days. Xingnaojing will be compared to placebo, combined with guidelines-based standard care in patients with acute ischemic stroke within 24 hours of symptom onset. All participants will have a National Institutes of Health Stroke Scale(NIHSS)entry score of 4-25. Participants who have planned or already received the intravenous thrombolysis or endovascular treatment will be excluded. The primary outcome will be determined at 90 days.
- Conditions
- Acute Ischemic Stroke, Stroke, Acute, Stroke, Ischemic
- Being tested
- Xingnaojing injection, Xingnaojing placebo injection, Standard care
- Keywords
- Acute ischemic stroke, Xingnaojing injection, Traditional Chinese Medicine, Double-Blind, Randomized Controlled Trial
- Medical subject headings
- Ischemic Stroke, 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)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days.
Xingnaojing placebo injectionDrug
Xingnaojing placebo injection (20 ml)+0.9% diluted sodium chloride injection 250ml, 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 | Experimental | Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care. Receives: Drug: Xingnaojing injection; Other: Standard care |
| Placebo | Placebo comparator | Subjects will receive intravenously administered Xingnaojing placebo, combined with guidelines-based standard care. Receives: Drug: Xingnaojing placebo injection; Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients independent.
Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.The Modified Rankin Scale Score ranges from 0 (best score) to 6 (worst score).
Measured: 90 days
Secondary outcomes (9)
Early neurological deterioration.
The early neurologic deterioration is defined as an increase of 1 points or more in the National Institute of Health Stroke Scale (NIHSS) score between baseline and 3 days. The NIHSS score ranges from 0 (best score) to 42 (worst score).
Measured: Baseline and 3 days
Neurological impairment evaluated by National Institute of Health Stroke Scale (NIHSS).
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
Patient reported outcome
Patient reported outcome (PRO) scale of stroke at 10 days.The PRO score ranges from 36(best score) to 180 (worst score).
Measured: 10 days
State of consciousness
The state of consciousness evaluated by Glasgow Coma Scale at 7 days. The Glasgow score ranges from 3(worst score) to 15 (best score).
Measured: 48 hours and 7 days
Activities of daily living
Activities of daily living will be measured by Barthel Index score at 30 days and 90 days.The Barthel Index score ranges from 0 (worst score) to 100 (best score).
Measured: 30 days and 90 days
The proportion of patients independent at 30 days.
The proportion of patients independent will be evaluated by mRS at 30 days.The mRS score ranges from 0 (best score) to 6 (worst score).
Measured: 30 days
The recurrence rate of cerebrovascular events
The recurrence rate of cerebrovascular events within 90 days.
Measured: Within 90 days
Stroke related deaths and deaths from any cause
Stroke related deaths and deaths from any cause within 10 days and 90 days after symptom onset.
Measured: Within 10 days and 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).
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start19 Mar 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital, Beijing Shuyi Hospital, The Airport Hospital of Shunyi District Beijing, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, The NO.4 People's Hospital of Hengshui, The Second Hospital of Hebei Medical University, The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine, Shaanxi Hospital of Traditional Chinese Medicine, Tianshui Hospital of Traditional Chinese Medicine, The Affiliated Hospital of Changzhi Academy of TCM, Zibo Hospital of Traditional Chinese Medicine, Yantai Yuhuangding Hospital, Shandong University of Traditional Chinese Medicine, Zhejiang Provincial Hospital of TCM, Zhejiang Provincial Tongde Hospital, Second Affiliated Hospital of Wenzhou Medical University, People's Hospital of Quzhou, Longhua Hospital, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Taizhou Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Guizhou University of TCM, Guangzhou Hospital of Traditional Chinese Medicine, First Affiliated Hospital of Guangxi Medical University, Liling Hospital of Traditional Chinese Medicine, Hunan Academy of Traditional Chinese Medicine Affiliated Hospital, Hubei Hospital of Traditional Chinese Medicine, The First Hospital of Jilin University, Anshan Central Hospital, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, The First Hospital of Qiqihar City, Haikou People's Hospital, The Second People's Hospital of Anhui Province, The Third Affiliated Hospital of Shenzhen University, The Third People's Hospital of Hubei Province, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, The Third Hospital of Xi'an City
- Responsible party
- Principal investigator, Ying Gao, Dongzhimen Hospital, Beijing
- Investigators
- Ying Gao, MD, Principal investigator, Dongzhimen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150835
- Sponsor's protocol ID
- 2018YFC1705001
- Acronym
- XMAS-2
- Status last verified
- Mar 2021
- First submitted
- 1 Nov 2019
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xingnaojing for Mild-to-severe Acute Ischemic Stroke (XMAS-2): A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT04150835
- Acronym / sponsor ID
- XMAS-2 / 2018YFC1705001
- Conditions
- Acute Ischemic Stroke, Stroke, Acute, Stroke, Ischemic
- Keywords
- Acute ischemic stroke, Xingnaojing injection, Traditional Chinese Medicine, Double-Blind, Randomized Controlled Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Collaborators
- Peking University Third Hospital, Beijing Shuyi Hospital, The Airport Hospital of Shunyi District Beijing, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, The NO.4 People's Hospital of Hengshui, The Second Hospital of Hebei Medical University, The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine, Shaanxi Hospital of Traditional Chinese Medicine, Tianshui Hospital of Traditional Chinese Medicine, The Affiliated Hospital of Changzhi Academy of TCM, Zibo Hospital of Traditional Chinese Medicine, Yantai Yuhuangding Hospital, Shandong University of Traditional Chinese Medicine, Zhejiang Provincial Hospital of TCM, Zhejiang Provincial Tongde Hospital, Second Affiliated Hospital of Wenzhou Medical University, People's Hospital of Quzhou, Longhua Hospital, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Taizhou Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Guizhou University of TCM, Guangzhou Hospital of Traditional Chinese Medicine, First Affiliated Hospital of Guangxi Medical University, Liling Hospital of Traditional Chinese Medicine, Hunan Academy of Traditional Chinese Medicine Affiliated Hospital, Hubei Hospital of Traditional Chinese Medicine, The First Hospital of Jilin University, Anshan Central Hospital, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, The First Hospital of Qiqihar City, Haikou People's Hospital, The Second People's Hospital of Anhui Province, The Third Affiliated Hospital of Shenzhen University, The Third People's Hospital of Hubei Province, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, The Third Hospital of Xi'an City
- Study start
- 19 Mar 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Nov 2019 (actual)
- 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 daily living ability of acute ischemic stroke at 90 days.
Detailed description
The XMAS-2 study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary hypothesis of this trial is that Xingnaojing will improve the daily living ability of acute ischemic stroke at 90 days. Xingnaojing will be compared to placebo, combined with guidelines-based standard care in patients with acute ischemic stroke within 24 hours of symptom onset. All participants will have a National Institutes of Health Stroke Scale(NIHSS)entry score of 4-25. Participants who have planned or already received the intravenous thrombolysis or endovascular treatment will be excluded. The primary outcome will be determined at 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xingnaojing | Experimental | Drug: Xingnaojing injection, Other: Standard careSubjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care. |
| Placebo | Placebo comparator | Drug: Xingnaojing placebo injection, Other: Standard careSubjects will receive intravenously administered Xingnaojing placebo, combined with guidelines-based standard care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Acute ischemic stroke；
- Symptom onset within 24 hours；
- Age ≥ 18 and ≤ 80 years；
- NIHSS score ≥ 4 and ≤ 25；
- Patient or legally authorized representative has signed informed consent.
Key exclusion criteria (10 listed)
- Planned or already receiving intravenous thrombolysis or endovascular treatment;
- Suspected secondary stroke caused by tumor, brain trauma, or hematological diseases;
- Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scale score ≥ 2) ;
- Other conditions that cause cardiogenic embolism (e.g., atrial fibrillation, rheumatic heart disease, valvular heart disease);
- Other conditions that lead to motor dysfunction (e.g., severe osteoarthrosis, rheumatoid arthritis);
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)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days. | Drug | Xingnaojing |
| Xingnaojing placebo injectionXingnaojing placebo injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days. | Drug | Placebo |
| Standard careGuidelines-based standard care for acute ischemic stroke. | Other | Placebo, Xingnaojing |
Primary outcome
The proportion of patients independent.
Time frame: 90 days
Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.The Modified Rankin Scale Score ranges from 0 (best score) to 6 (worst score).
9 secondary outcomes
Early neurological deterioration.
Time frame: Baseline and 3 days
Neurological impairment evaluated by National Institute of Health Stroke Scale (NIHSS).
Time frame: Baseline and 10 days
Patient reported outcome
Time frame: 10 days
State of consciousness
Time frame: 48 hours and 7 days
Activities of daily living
Time frame: 30 days and 90 days
The proportion of patients independent at 30 days.
Time frame: 30 days
The recurrence rate of cerebrovascular events
Time frame: Within 90 days
Stroke related deaths and deaths from any cause
Time frame: Within 10 days and 90 days
Safety end points
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- 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 and Stroke, Acute, 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 5 inclusion and 10 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 1 Apr 2021. 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. Some participants in this study may receive a placebo. 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?
Contact Ying Gao, MD (0086-010-84013209, gaoying973@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 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?
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 1 Apr 2021.