StrokeTRACENCT04275349
Trial of pRehospital Intervention With trAditional Chinese Medicine for Acute strokE
An observational study of Stroke and Acute Ischemic Stroke, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial summary
The main purpose of this trial is to observe whether Xingnaojing, intravenously administered within 24 hours of symptom onset on pre-hospital emergency ambulance, improves the Early neurological deterioration of acute stroke at 3 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute Ischemic Stroke, Acute Intracranial Hemorrhage
- What is being tested?
- Xingnaojing injection within 24 hours of symptom onset
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2020to Dec 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: suspected acute stroke patient (call for emergency ambulance)
Who may be able to join
- Diagnosis of suspected acute stroke；
- Symptom onset within 24 hours；
- Age ≥ 18 .
Who cannot join
- Other conditions that lead to motor dysfunction (e.g., severe osteoarthrosis, rheumatoid arthritis);
- Other conditions that render outcomes or follow-up unlikely to be assessed; Known to be pregnant or breastfeeding;
- Non-acute stroke (result from Computed Tomography(CT) or Magnetic Resonance Imaging(MRI)).
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
Lingbo Kong, MD, 0086-13167323987, klb1984@163.com
About this study
Official title: Trial of pRehospital Intervention With trAditional Chinese Medicine for Acute strokE: A Mixed Methods Research
The main purpose of this trial is to observe whether Xingnaojing, intravenously administered within 24 hours of symptom onset on pre-hospital emergency ambulance, improves the Early neurological deterioration of acute stroke at 3 days.
Read the detailed description
The TRACE is a multicenter, registry observational study. Xingnaojing injection is the only essential traditional chinese medicine on emergency ambulance used for acute stroke.The primary hypothesis of this trial is that Xingnaojing used for acute stroke within 24 hours of symptom onset on ambulance will improve the Early neurological deterioration of acute stroke at 3 days. All suspected acute stroke participants will be registered once they are taken on the ambulance. The primary outcome will be determined at 3 days.Besides, there will be a quantitative interview with emergency doctors about their knowledge and attitude on Xingnaojing for acute stroke patients.
- Conditions
- Stroke, Acute Ischemic Stroke, Acute Intracranial Hemorrhage
- Being tested
- Xingnaojing injection within 24 hours of symptom onset
- Keywords
- Registry, Cohort study, Mixed methods, Prehospital, Stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xingnaojing injection within 24 hours of symptom onsetDrug
intravenously administered Xingnaojing injection within 24 hours of symptom onset on ambulance or at hospital
| Study group | Role | What they receive |
|---|---|---|
| Exposure group(continuously) | xingnaojing injection will be intravenously administered within 24 hours of symptom onset until to third day (from prehospital ambulance to hospital or at hospital) Receives: Drug: Xingnaojing injection within 24 hours of symptom onset | |
| Exposure group(uncontinuously) | xingnaojing injection will be intravenously administered within 24 hours of symptom onset for once (on prehospital ambulance ) Receives: Drug: Xingnaojing injection within 24 hours of symptom onset | |
| Completely unexposed group | xingnaojing injection will not be intravenously administered within 24 hours of symptom onset until to third day (from prehospital ambulance to hospital) | |
| Incompletely unexposed group | xingnaojing injection will not be intravenously administered on ambulance but administered more than 24 hours of symptom onset at hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early neurological deterioration（change between baseline and 3 days)
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: 3 days
Secondary outcomes (5)
Rate of stroke related deaths and deaths from any cause
Rate of stroke related deaths and deaths from any cause during hospitalization
Measured: 14 days during hospitalization
Neurological impairment
Evaluated by National Institute of Health Stroke Scale (NIHSS)
Measured: Baseline and day of discharge or 10 days
Risk grade of cerebral hemorrhage
Intracranial hemorrhage evaluated by Intracerebral Haemorrhage(ICH) scale.
Measured: Baseline and day of discharge or 10 days
Activities of daily living
Activities of daily living will be measured by Barthel Index (BI)score at 30 days and 90 days.The Barthel Index score ranges from 0 (worst score) to 100 (best score).
Measured: 30 days,60 days and 90 days
The proportion of patients independent
The proportion of patients independent will be evaluated by modified Rankin Scale(mRS).The mRS score ranges from 0 (best score) to 6 (worst score).
Measured: 30 days,60 days and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start20 Mar 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Emergency Medical Center, Beijing Tiantan Hospital, Beijing Hospital of Traditional Chinese Medicine, Centre for Evidence Based Chinese Medicine, Beijing University of Chinese Medicine, Xuanwu Hospital, Beijing, Beijing Friendship Hospital, Beijing Chao Yang Hospital, Beijing Shijitan Hospital, Capital Medical University, Beijing Fengtai Youanmen Hospital, Beijing Jiangong Hospital, Beijing Chaoyang Emergency Medical Center, Beijing Chaoyang Integrative Medicine Emergency Medical Center, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Fangshan Hospital，Beijing University of Chinese Medicine, Civil Aviation General Hospital, The First Hospital of Fangshan District,Beijing, Beijing Chinese Medicine Hospital-Pinggu Hospital, Beijing Pinggu District Hospital
- Responsible party
- Principal investigator, Ying Gao, Dongzhimen Hospital, Beijing
- Investigators
- Ying Gao, MD, Principal investigator, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275349
- Sponsor's protocol ID
- CFH 2018-1-4191
- Acronym
- TRACE
- Status last verified
- Jun 2020
- First submitted
- 7 Feb 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen Y, Qi D, Che S, Chang Z, Zhong D, Hao Y, Guo Y, Kong L. Effectiveness and safety of xingnaojing injection within 24 hours for acute ischemic stroke: a multicenter prospective cohort study (TRACE). Front Pharmacol. 2026 Aug 12;17:1697607. doi: 10.3389/fphar.2026.1697607. eCollection 2026.
PubMed 42656564Chen Y, Tian Z, Wang S, Liu H, Liu Y, Peng W, Lai X, Qi D, Kong L, Gao Y. Trial of a prehospital intervention with traditional Chinese medicine for acute stroke (TRACE): Protocol for a mixed-methods research study. Front Pharmacol. 2022 Aug 29;13:879282. doi: 10.3389/fphar.2022.879282. eCollection 2022.
PubMed 36105230
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of pRehospital Intervention With trAditional Chinese Medicine for Acute strokE: A Mixed Methods Research
- ClinicalTrials.gov ID
- NCT04275349
- Acronym / sponsor ID
- TRACE / CFH 2018-1-4191
- Conditions
- Stroke, Acute Ischemic Stroke, Acute Intracranial Hemorrhage
- Keywords
- Registry, Cohort study, Mixed methods, Prehospital, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Collaborators
- Beijing Emergency Medical Center, Beijing Tiantan Hospital, Beijing Hospital of Traditional Chinese Medicine, Centre for Evidence Based Chinese Medicine, Beijing University of Chinese Medicine, Xuanwu Hospital, Beijing, Beijing Friendship Hospital, Beijing Chao Yang Hospital, Beijing Shijitan Hospital, Capital Medical University, Beijing Fengtai Youanmen Hospital, Beijing Jiangong Hospital, Beijing Chaoyang Emergency Medical Center, Beijing Chaoyang Integrative Medicine Emergency Medical Center, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Fangshan Hospital，Beijing University of Chinese Medicine, Civil Aviation General Hospital, The First Hospital of Fangshan District,Beijing, Beijing Chinese Medicine Hospital-Pinggu Hospital, Beijing Pinggu District Hospital
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 19 Feb 2020 (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 observe whether Xingnaojing, intravenously administered within 24 hours of symptom onset on pre-hospital emergency ambulance, improves the Early neurological deterioration of acute stroke at 3 days.
Detailed description
The TRACE is a multicenter, registry observational study. Xingnaojing injection is the only essential traditional chinese medicine on emergency ambulance used for acute stroke.The primary hypothesis of this trial is that Xingnaojing used for acute stroke within 24 hours of symptom onset on ambulance will improve the Early neurological deterioration of acute stroke at 3 days. All suspected acute stroke participants will be registered once they are taken on the ambulance. The primary outcome will be determined at 3 days.Besides, there will be a quantitative interview with emergency doctors about their knowledge and attitude on Xingnaojing for acute stroke patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exposure group(continuously) | – | Drug: Xingnaojing injection within 24 hours of symptom onsetxingnaojing injection will be intravenously administered within 24 hours of symptom onset until to third day (from prehospital ambulance to hospital or at hospital) |
| Exposure group(uncontinuously) | – | Drug: Xingnaojing injection within 24 hours of symptom onsetxingnaojing injection will be intravenously administered within 24 hours of symptom onset for once (on prehospital ambulance ) |
| Completely unexposed group | – | –xingnaojing injection will not be intravenously administered within 24 hours of symptom onset until to third day (from prehospital ambulance to hospital) |
| Incompletely unexposed group | – | –xingnaojing injection will not be intravenously administered on ambulance but administered more than 24 hours of symptom onset at hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- suspected acute stroke patient (call for emergency ambulance)
Key inclusion criteria (3 listed)
- Diagnosis of suspected acute stroke；
- Symptom onset within 24 hours；
- Age ≥ 18 .
Key exclusion criteria (3 listed)
- Other conditions that lead to motor dysfunction (e.g., severe osteoarthrosis, rheumatoid arthritis);
- Other conditions that render outcomes or follow-up unlikely to be assessed; Known to be pregnant or breastfeeding;
- Non-acute stroke (result from Computed Tomography(CT) or Magnetic Resonance Imaging(MRI)).
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 injection within 24 hours of symptom onsetintravenously administered Xingnaojing injection within 24 hours of symptom onset on ambulance or at hospital | Drug | Exposure group(continuously), Exposure group(uncontinuously) |
Primary outcome
Early neurological deterioration（change between baseline and 3 days)
Time frame: 3 days
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).
5 secondary outcomes
Rate of stroke related deaths and deaths from any cause
Time frame: 14 days during hospitalization
Neurological impairment
Time frame: Baseline and day of discharge or 10 days
Risk grade of cerebral hemorrhage
Time frame: Baseline and day of discharge or 10 days
Activities of daily living
Time frame: 30 days,60 days and 90 days
The proportion of patients independent
Time frame: 30 days,60 days and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 42656564Chen Y, Qi D, Che S, Chang Z, Zhong D, Hao Y, Guo Y, Kong L. Effectiveness and safety of xingnaojing injection within 24 hours for acute ischemic stroke: a multicenter prospective cohort study (TRACE). Front Pharmacol. 2026 Aug 12;17:1697607. doi: 10.3389/fphar.2026.1697607. eCollection 2026.
- Derived from this study: PubMed 36105230Chen Y, Tian Z, Wang S, Liu H, Liu Y, Peng W, Lai X, Qi D, Kong L, Gao Y. Trial of a prehospital intervention with traditional Chinese medicine for acute stroke (TRACE): Protocol for a mixed-methods research study. Front Pharmacol. 2022 Aug 29;13:879282. doi: 10.3389/fphar.2022.879282. eCollection 2022.
- 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, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and 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 3 inclusion and 3 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 11 Jun 2020. 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.
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?
Early neurological deterioration（change between baseline and 3 days) (time frame: 3 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 NCT04275349, which also lists 2 linked publications.
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 11 Jun 2020.