Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice
1 other identifier
observational
2,408
1 country
78
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2023
CompletedFirst Posted
Study publicly available on registry
August 30, 2023
CompletedStudy Start
First participant enrolled
September 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2025
CompletedFebruary 27, 2026
September 1, 2025
1.9 years
August 24, 2023
February 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of mRS (0-1)
The modified Rankin Scale (mRS) score ranges from 0 (best score) to 6 (worst score).
90±7 days
Secondary Outcomes (7)
Proportion of mRS (0-2)
90±7 days
Proportion of mRS (0-1) or returning to baseline
90±7 days
Distribution of mRS
90±7 days
Change of NIHSS
baseline, 14 days or the day of discharge
BI
90±7 days
- +2 more secondary outcomes
Study Arms (2)
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.
Non-exposure group
The non-exposed group was defined as patients receiving guideline-standardized treatment after intravenous alteplase or tenecteplase.
Interventions
Eligibility Criteria
Patients with acute ischemic stroke who received alteplase or tenecteplase within 4.5 hours of onset
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
Beijing Royal Integrative Medicine Hospital
Beijing, Beijing Municipality, China
China Aerospace Science and Industry Corporation 731 Hospital
Beijing, Beijing Municipality, China
Chongqing Chinese Medicine Hospital
Chongqing, Chongqing Municipality, China
University-Town Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Nanning First People's Hospital
Nanning, Guangxi, China
Guizhou People's Hospital
Guiyang, Guizhou, China
Hebei CangZhou Hospital of Integrated Traditional Chinese and Western Medicine
Cangzhou, Hebei, China
Tangshan Central Hospital
Tangshan, Hebei, China
The First Affiliated Hospital Of Harbin Medical University
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Hongqi Hospital Affiliated to Mudanjiang Medical University
Mudanjiang, Heilongjiang, China
Anyang Third People's Hospital
Anyang, Henan, China
Huaxian People's Hospital
Anyang, Henan, China
Neihuang People's Hospital
Anyang, Henan, China
Jiaozuo Second People's Hospital
Jiaozuo, Henan, China
Kaifeng People's Hospital
Kaifeng, Henan, China
Luohe Sixth People's Hospital
Luohe, Henan, China
Nanyang Nanshi Hospital
Nanyang, Henan, China
Baofeng Chinese Medicine Hospital
Pingdingshan, Henan, China
Baofeng People's Hospital
Pingdingshan, Henan, China
Pingdingshan First People's Hospital
Pingdingshan, Henan, China
Ye County People's Hospital
Pingdingshan, Henan, China
Shangqiu Municipal Hospital
Shangqiu, Henan, China
Changyuan Chinese Medicine Hospital
Xinxiang, Henan, China
The First Affiliated Hospital Of Xinxiang Medical University
Xinxiang, Henan, China
Xinxiang Central Hospital
Xinxiang, Henan, China
Xinxiang First People's Hospital
Xinxiang, Henan, China
Xi County Central Hospital
Xinyang, Henan, China
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, China
Runan People's Hospital
Zhumadian, Henan, China
Changsha First Hospital
Changsha, Hunan, China
The Affiliated Hospital of Hunan Academy of Chinese Medicine
Changsha, Hunan, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Hunan, China
Nanjing Chinese Medicine Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Pengzhou Chinese Medicine Hospital
Pengzhou, Jiangsu, China
Yancheng First People's Hospital
Yancheng, Jiangsu, China
Gaoxin Hospital Of The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
Jiangxi People's Hospital
Nanchang, Jiangxi, China
Jilin Central General Hospital
Jilin, Jilin, China
Songyuan Jilin Oifield Hospital
Songyuan, Jilin, China
Anshan Central Hospital
Anshan, Liaoning, China
967 Hospital of The Joint Logistics Support Force of PLA
Dalian, Liaoning, China
Central Hospital Affiliated Dalian University of Technology
Dalian, Liaoning, China
Dalian University Affiliated Xinhua Hospital
Dalian, Liaoning, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Jinzhou Central Hospital
Jinzhou, Liaoning, China
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Tieling Central Hospital
Tieling, Liaoning, China
Binzhou Medical University Hospital/ The First School of Clinical Medicine of Binzhou Medical University
Binzhou, Shandong, China
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China
The Second Hospital of Shandong University
Jinan, Shandong, China
Liaocheng Third People's Hospital
Liaocheng, Shandong, China
Linyi Hospital of Traditional Chinese Medicine
Linyi, Shandong, China
Ningjin People's Hospital
Ningjin, Shandong, China
Qingdao Huangdao District Chinese Medicine Hospital
Qingdao, Shandong, China
Weihai Wendeng District People's Hospital
Weihai, Shandong, China
Zibo First Hospital
Zibo, Shandong, China
Zibo Hospital of Traditional Chinese Medicine
Zibo, Shandong, China
Shanghai Pingdingshan Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Affiliated Hospital Of Changzhi Institute Of TCM
Changzhi, Shanxi, China
Gujiao Central Hospital
Taiyuan, Shanxi, China
Chengdu Integrated TCM & Western Medicine Hospital
Chengdu, Sichuan, China
Chengdu Seventh People's Hospital
Chengdu, Sichuan, China
Chengdu Shuangliu District Chinese Medicine Hospital
Chengdu, Sichuan, China
Chengdu Xinjin District Chinese Medicine Hospital
Chengdu, Sichuan, China
Jintang Second People's Hospital
Chengdu, Sichuan, China
Sichuan Tianfu People's Hospital
Chengdu, Sichuan, China
The Fourth People's Hospital of Sichuan Province
Chengdu, Sichuan, China
Xuyong Chinese Medicine Hospital
Luzhou, Sichuan, China
Qingshen People's Hospital
Meishan, Sichuan, China
Mianyang Third People's Hospital
Mianyang, Sichuan, China
Nanchong Central Hospital
Nanchong, Sichuan, China
Panzhihua Central Hospital
Panzhihua, Sichuan, China
Yibin Chinese Medicine Hospital
Yibin, Sichuan, China
Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital
Beijing, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 90 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
August 24, 2023
First Posted
August 30, 2023
Study Start
September 28, 2023
Primary Completion
August 28, 2025
Study Completion
September 3, 2025
Last Updated
February 27, 2026
Record last verified: 2025-09