Ischemic Stroke, AcuteNCT06018181
Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice
An observational study of Ischemic Stroke, Acute, run by Dongzhimen Hospital, Beijing at 78 sites in China.
Trial summary
Acute ischemic stroke is one of the main diseases leading to high risk of disability and morbidity worldwide. Since intravenous thrombolysis(IVT) can effectively improve the long-term functional prognosis of acute ischemic stroke(AIS), IVT within 4.5 hours of onset has been widely recommended by international… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Acute
- What is being tested?
- Shuxuetong Injection
- Type of treatment
- Injection or infusion
- How many people
- 2,408 participants
- Where
- 78 sitesChina
- Study dates
- 28 Sep 2023to 3 Sep 2025
- How long will I take part?
- 90 Days
- 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: Patients with acute ischemic stroke who received alteplase or tenecteplase within 4.5 hours of onset
Who may be able to join
- Hospitalized patients aged ≥18 years
- Diagnosis of acute ischemic stroke
- Receiving alteplase or tenecteplase treatment ≤ 4.5 hours of onset
- Signed informed consent by patient or legally authorized representatives
Who cannot join
- Having received or planing to undergo endovascular therapy (including mechanical thrombectomy, arterial thrombolysis, angioplasty, etc.)
- Life expectancy is less than 90 days
- Other factors that the researchers think are not suitable for participating in the research
- Currently receiving any experimental treatment
Trial locations and contacts
78 sites in 1 country.
78 sites in 1 country
China78 sites
Anshan Central Hospital
Anshan, Liaoning
Anyang Third People's Hospital
Anyang, Henan
Huaxian People's Hospital
Anyang, Henan
Neihuang People's Hospital
Anyang, Henan
Beijing Royal Integrative Medicine Hospital
Beijing, Beijing Municipality
China Aerospace Science and Industry Corporation 731 Hospital
Beijing, Beijing Municipality
Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital
Beijing
Binzhou Medical University Hospital/ The First School of Clinical Medicine of Binzhou Medical University
Binzhou, Shandong
Hebei CangZhou Hospital of Integrated Traditional Chinese and Western Medicine
Cangzhou, Hebei
Changsha First Hospital
Changsha, Hunan
The Affiliated Hospital of Hunan Academy of Chinese Medicine
Changsha, Hunan
Affiliated Hospital Of Changzhi Institute Of TCM
Changzhi, Shanxi
Chengdu Integrated TCM & Western Medicine Hospital
Chengdu, Sichuan
Chengdu Seventh People's Hospital
Chengdu, Sichuan
Chengdu Shuangliu District Chinese Medicine Hospital
Chengdu, Sichuan
Chengdu Xinjin District Chinese Medicine Hospital
Chengdu, Sichuan
Jintang Second People's Hospital
Chengdu, Sichuan
Sichuan Tianfu People's Hospital
Chengdu, Sichuan
The Fourth People's Hospital of Sichuan Province
Chengdu, Sichuan
Chongqing Chinese Medicine Hospital
Chongqing, Chongqing Municipality
University-Town Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
967 Hospital of The Joint Logistics Support Force of PLA
Dalian, Liaoning
Central Hospital Affiliated Dalian University of Technology
Dalian, Liaoning
Dalian University Affiliated Xinhua Hospital
Dalian, Liaoning
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Guizhou People's Hospital
Guiyang, Guizhou
The First Affiliated Hospital Of Harbin Medical University
Harbin, Heilongjiang
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Jiaozuo Second People's Hospital
Jiaozuo, Henan
Jilin Central General Hospital
Jilin City, Jilin
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong
The Second Hospital of Shandong University
Jinan, Shandong
Jinzhou Central Hospital
Jinzhou, Liaoning
Kaifeng People's Hospital
Kaifeng, Henan
Liaocheng Third People's Hospital
Liaocheng, Shandong
Linyi Hospital of Traditional Chinese Medicine
Linyi, Shandong
Luohe Sixth People's Hospital
Luohe, Henan
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Hunan
Xuyong Chinese Medicine Hospital
Luzhou, Sichuan
Qingshen People's Hospital
Meishan, Sichuan
Mianyang Third People's Hospital
Mianyang, Sichuan
Hongqi Hospital Affiliated to Mudanjiang Medical University
Mudanjiang, Heilongjiang
Gaoxin Hospital Of The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi
Jiangxi People's Hospital
Nanchang, Jiangxi
Nanchong Central Hospital
Nanchong, Sichuan
Nanjing Chinese Medicine Hospital
Nanjing, Jiangsu
Nanning First People's Hospital
Nanning, Guangxi
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Nanyang Nanshi Hospital
Nanyang, Henan
Ningjin People's Hospital
Ningjin, Shandong
Panzhihua Central Hospital
Panzhihua, Sichuan
Pengzhou Chinese Medicine Hospital
Pengzhou, Jiangsu
Baofeng Chinese Medicine Hospital
Pingdingshan, Henan
Baofeng People's Hospital
Pingdingshan, Henan
Pingdingshan First People's Hospital
Pingdingshan, Henan
Ye County People's Hospital
Pingdingshan, Henan
Qingdao Huangdao District Chinese Medicine Hospital
Qingdao, Shandong
Shanghai Pingdingshan Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality
Shangqiu Municipal Hospital
Shangqiu, Henan
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning
The First Hospital of China Medical University
Shenyang, Liaoning
Songyuan Jilin Oifield Hospital
Songyuan, Jilin
Gujiao Central Hospital
Taiyuan, Shanxi
Tangshan Central Hospital
Tangshan, Hebei
Tieling Central Hospital
Tieling, Liaoning
Weihai Wendeng District People's Hospital
Weihai, Shandong
Changyuan Chinese Medicine Hospital
Xinxiang, Henan
The First Affiliated Hospital Of Xinxiang Medical University
Xinxiang, Henan
Xinxiang Central Hospital
Xinxiang, Henan
Xinxiang First People's Hospital
Xinxiang, Henan
Xi County Central Hospital
Xinyang, Henan
Yancheng First People's Hospital
Yancheng, Jiangsu
Yibin Chinese Medicine Hospital
Yibin, Sichuan
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan
Runan People's Hospital
Zhumadian, Henan
Zibo First Hospital
Zibo, Shandong
Zibo Hospital of Traditional Chinese Medicine
Zibo, Shandong
About this study
Official title: Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice: A Patient Registry
Acute ischemic stroke is one of the main diseases leading to high risk of disability and morbidity worldwide. Since intravenous thrombolysis(IVT) can effectively improve the long-term functional prognosis of acute ischemic stroke(AIS), IVT within 4.5 hours of onset has been widely recommended by international guidelines.
Although 35-53% of AIS patients achieve functional independence after receiving IVT, there are still a large number of patients who are disabled or even dead, and nearly 70% of patients have ineffective recanalization. Therefore, there is an urgent need for therapeutic drugs after IVT to further improve the prognosis and reduce the burden of AIS.
Shuxuetong injection is widely used in China in patients with AIS after IVT, but the situation in real clinical practice is unclear. Therefore, the study aims to evaluate the effectiveness and safety of Shuxuetong Injection in patients with AIS treated with intravenous alteplase and tenecteplase, and obtain high-quality clinical evidence.
- Conditions
- Ischemic Stroke, Acute
- Being tested
- Shuxuetong Injection
- Keywords
- Shuxuetong Injection, Intravenous Thrombolysis, Patient Registry
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shuxuetong InjectionDrug
According to clinical real treatment records
| Study group | Role | What they receive |
|---|---|---|
| Exposure group | The exposure group was defined as patients receiving Shuxuetong injection and guideline-standardized treatment after intravenous alteplase or tenecteplase.
Mainly based on the following guidelines:(1)Guidelines for the diagnosis and treatment of acute ischemic stroke in China 2018; (2)Guidelines for secondary prevention of ischemic stroke and transient ischemic attack in China 2022. Receives: Drug: Shuxuetong Injection | |
| Non-exposure group | The non-exposed group was defined as patients receiving guideline-standardized treatment after intravenous alteplase or tenecteplase. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of mRS (0-1)
The modified Rankin Scale (mRS) score ranges from 0 (best score) to 6 (worst score).
Measured: 90±7 days
Secondary outcomes (7)
Proportion of mRS (0-2)
Measured: 90±7 days
Proportion of mRS (0-1) or returning to baseline
Measured: 90±7 days
Distribution of mRS
Measured: 90±7 days
Change of NIHSS
The change in the National Institute of Health Stroke Scale (NIHSS) scores from baseline to 14 days or the day of discharge. The NIHSS score ranges from 0 (best score) to 42 (worst score).
Measured: baseline, 14 days or the day of discharge
BI
The Barthel Index (BI) score ranges from 0 (worst score) to 100 (best score).
Measured: 90±7 days
Total mortality
The occurrence of mortality of any cause within 90 days.
Measured: Within 90 days
Serious Adverse Events
The occurrence of serious adverse events including any event resulting in prolonged hospital time, permanent damage to the body system or organ, a life-threatening condition or death within 90 days.
Measured: Within 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start28 Sep 2023
- Primary completion28 Aug 2025
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies 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
- 2,408 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Gao, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018181
- Sponsor's protocol ID
- 2022YFC3501104-01
- Status last verified
- Sep 2025
- First submitted
- 24 Aug 2023
- Last updated
- 27 Feb 2026
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice: A Patient Registry
- ClinicalTrials.gov ID
- NCT06018181
- Acronym / sponsor ID
- 2022YFC3501104-01
- Conditions
- Ischemic Stroke, Acute
- Keywords
- Shuxuetong Injection, Intravenous Thrombolysis, Patient Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,408 participants (actual)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 30 Aug 2023 (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.
Acute ischemic stroke is one of the main diseases leading to high risk of disability and morbidity worldwide. Since intravenous thrombolysis(IVT) can effectively improve the long-term functional prognosis of acute ischemic stroke(AIS), IVT within 4.5 hours of onset has been widely recommended by international guidelines.
Although 35-53% of AIS patients achieve functional independence after receiving IVT, there are still a large number of patients who are disabled or even dead, and nearly 70% of patients have ineffective recanalization. Therefore, there is an urgent need for therapeutic drugs after IVT to further improve the prognosis and reduce the burden of AIS.
Shuxuetong injection is widely used in China in patients with AIS after IVT, but the situation in real clinical practice is unclear. Therefore, the study aims to evaluate the effectiveness and safety of Shuxuetong Injection in patients with AIS treated with intravenous alteplase and tenecteplase, and obtain high-quality clinical evidence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure group | – | Drug: Shuxuetong InjectionThe exposure group was defined as patients receiving Shuxuetong injection and guideline-standardized treatment after intravenous alteplase or tenecteplase. Mainly based on the following guidelines:(1)Guidelines for the diagnosis and treatment of acute ischemic stroke in China 2018; (2)Guidelines for secondary prevention of ischemic stroke and transient ischemic attack in China 2022. |
| Non-exposure group | – | –The non-exposed group was defined as patients receiving guideline-standardized treatment after intravenous alteplase or tenecteplase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke who received alteplase or tenecteplase within 4.5 hours of onset
Key inclusion criteria (4 listed)
- Hospitalized patients aged ≥18 years
- Diagnosis of acute ischemic stroke
- Receiving alteplase or tenecteplase treatment ≤ 4.5 hours of onset
- Signed informed consent by patient or legally authorized representatives
Key exclusion criteria (4 listed)
- Having received or planing to undergo endovascular therapy (including mechanical thrombectomy, arterial thrombolysis, angioplasty, etc.)
- Life expectancy is less than 90 days
- Other factors that the researchers think are not suitable for participating in the research
- Currently receiving any experimental treatment
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 |
|---|---|---|
| Shuxuetong InjectionAccording to clinical real treatment records | Drug | Exposure group |
Primary outcome
Proportion of mRS (0-1)
Time frame: 90±7 days
The modified Rankin Scale (mRS) score ranges from 0 (best score) to 6 (worst score).
7 secondary outcomes
Proportion of mRS (0-2)
Time frame: 90±7 days
Proportion of mRS (0-1) or returning to baseline
Time frame: 90±7 days
Distribution of mRS
Time frame: 90±7 days
Change of NIHSS
Time frame: baseline, 14 days or the day of discharge
BI
Time frame: 90±7 days
Total mortality
Time frame: Within 90 days
Serious Adverse Events
Time frame: Within 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
78 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, Acute, run by Dongzhimen Hospital, Beijing at 78 sites 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 4 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 mRS (0-1) (time frame: 90±7 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 27 Feb 2026.