Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice

NCT ID: NCT06018181

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2008 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-28

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Stroke, Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Shuxuetong Injection

Intervention Type DRUG

According to clinical real treatment records

Non-exposure group

The non-exposed group was defined as patients receiving guideline-standardized treatment after intravenous alteplase or tenecteplase.

No interventions assigned to this group

Interventions

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Shuxuetong Injection

According to clinical real treatment records

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dongzhimen Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Ying Gao

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Royal Integrative Medicine Hospital

Beijing, Beijing Municipality, China

Site Status COMPLETED

China Aerospace Science and Industry Corporation 731 Hospital

Beijing, Beijing Municipality, China

Site Status COMPLETED

Chongqing Chinese Medicine Hospital

Chongqing, Chongqing Municipality, China

Site Status COMPLETED

University-Town Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status COMPLETED

Nanning First People's Hospital

Nanning, Guangxi, China

Site Status COMPLETED

Guizhou People's Hospital

Guiyang, Guizhou, China

Site Status COMPLETED

Hebei CangZhou Hospital of Integrated Traditional Chinese and Western Medicine

Cangzhou, Hebei, China

Site Status COMPLETED

Tangshan Central Hospital

Tangshan, Hebei, China

Site Status COMPLETED

The First Affiliated Hospital Of Harbin Medical University

Harbin, Heilongjiang, China

Site Status RECRUITING

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status COMPLETED

Hongqi Hospital Affiliated to Mudanjiang Medical University

Mudanjiang, Heilongjiang, China

Site Status COMPLETED

Anyang Third People's Hospital

Anyang, Henan, China

Site Status COMPLETED

Huaxian People's Hospital

Anyang, Henan, China

Site Status COMPLETED

Neihuang People's Hospital

Anyang, Henan, China

Site Status COMPLETED

Jiaozuo Second People's Hospital

Jiaozuo, Henan, China

Site Status COMPLETED

Kaifeng People's Hospital

Kaifeng, Henan, China

Site Status COMPLETED

Luohe Sixth People's Hospital

Luohe, Henan, China

Site Status COMPLETED

Nanyang Nanshi Hospital

Nanyang, Henan, China

Site Status COMPLETED

Baofeng Chinese Medicine Hospital

Pingdingshan, Henan, China

Site Status COMPLETED

Baofeng People's Hospital

Pingdingshan, Henan, China

Site Status COMPLETED

Pingdingshan First People's Hospital

Pingdingshan, Henan, China

Site Status COMPLETED

Ye County People's Hospital

Pingdingshan, Henan, China

Site Status COMPLETED

Shangqiu Municipal Hospital

Shangqiu, Henan, China

Site Status COMPLETED

Changyuan Chinese Medicine Hospital

Xinxiang, Henan, China

Site Status COMPLETED

The First Affiliated Hospital Of Xinxiang Medical University

Xinxiang, Henan, China

Site Status COMPLETED

Xinxiang Central Hospital

Xinxiang, Henan, China

Site Status COMPLETED

Xinxiang First People's Hospital

Xinxiang, Henan, China

Site Status COMPLETED

Xi County Central Hospital

Xinyang, Henan, China

Site Status COMPLETED

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, China

Site Status COMPLETED

Runan People's Hospital

Zhumadian, Henan, China

Site Status COMPLETED

Changsha First Hospital

Changsha, Hunan, China

Site Status COMPLETED

The Affiliated Hospital of Hunan Academy of Chinese Medicine

Changsha, Hunan, China

Site Status COMPLETED

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Hunan, China

Site Status COMPLETED

Nanjing Chinese Medicine Hospital

Nanjing, Jiangsu, China

Site Status COMPLETED

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Site Status COMPLETED

Pengzhou Chinese Medicine Hospital

Pengzhou, Jiangsu, China

Site Status COMPLETED

Yancheng First People's Hospital

Yancheng, Jiangsu, China

Site Status COMPLETED

Gaoxin Hospital Of The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, China

Site Status COMPLETED

Jiangxi People's Hospital

Nanchang, Jiangxi, China

Site Status COMPLETED

Jilin Central General Hospital

Jilin, Jilin, China

Site Status COMPLETED

Songyuan Jilin Oifield Hospital

Songyuan, Jilin, China

Site Status COMPLETED

Anshan Central Hospital

Anshan, Liaoning, China

Site Status COMPLETED

967 Hospital of The Joint Logistics Support Force of PLA

Dalian, Liaoning, China

Site Status COMPLETED

Central Hospital Affiliated Dalian University of Technology

Dalian, Liaoning, China

Site Status COMPLETED

Dalian University Affiliated Xinhua Hospital

Dalian, Liaoning, China

Site Status COMPLETED

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status RECRUITING

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status COMPLETED

Jinzhou Central Hospital

Jinzhou, Liaoning, China

Site Status COMPLETED

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, China

Site Status COMPLETED

The First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status COMPLETED

Tieling Central Hospital

Tieling, Liaoning, China

Site Status COMPLETED

Binzhou Medical University Hospital/ The First School of Clinical Medicine of Binzhou Medical University

Binzhou, Shandong, China

Site Status COMPLETED

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, China

Site Status COMPLETED

The Second Hospital of Shandong University

Jinan, Shandong, China

Site Status COMPLETED

Liaocheng Third People's Hospital

Liaocheng, Shandong, China

Site Status COMPLETED

Linyi Hospital of Traditional Chinese Medicine

Linyi, Shandong, China

Site Status COMPLETED

Ningjin People's Hospital

Ningjin, Shandong, China

Site Status COMPLETED

Qingdao Huangdao District Chinese Medicine Hospital

Qingdao, Shandong, China

Site Status RECRUITING

Weihai Wendeng District People's Hospital

Weihai, Shandong, China

Site Status COMPLETED

Zibo First Hospital

Zibo, Shandong, China

Site Status COMPLETED

Zibo Hospital of Traditional Chinese Medicine

Zibo, Shandong, China

Site Status COMPLETED

Shanghai Pingdingshan Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Site Status COMPLETED

Affiliated Hospital Of Changzhi Institute Of TCM

Changzhi, Shanxi, China

Site Status COMPLETED

Gujiao Central Hospital

Taiyuan, Shanxi, China

Site Status COMPLETED

Chengdu Integrated TCM & Western Medicine Hospital

Chengdu, Sichuan, China

Site Status COMPLETED

Chengdu Seventh People's Hospital

Chengdu, Sichuan, China

Site Status COMPLETED

Chengdu Shuangliu District Chinese Medicine Hospital

Chengdu, Sichuan, China

Site Status COMPLETED

Chengdu Xinjin District Chinese Medicine Hospital

Chengdu, Sichuan, China

Site Status COMPLETED

Jintang Second People's Hospital

Chengdu, Sichuan, China

Site Status COMPLETED

Sichuan Tianfu People's Hospital

Chengdu, Sichuan, China

Site Status COMPLETED

The Fourth People's Hospital of Sichuan Province

Chengdu, Sichuan, China

Site Status COMPLETED

Xuyong Chinese Medicine Hospital

Luzhou, Sichuan, China

Site Status COMPLETED

Qingshen People's Hospital

Meishan, Sichuan, China

Site Status COMPLETED

Mianyang Third People's Hospital

Mianyang, Sichuan, China

Site Status COMPLETED

Nanchong Central Hospital

Nanchong, Sichuan, China

Site Status COMPLETED

Panzhihua Central Hospital

Panzhihua, Sichuan, China

Site Status COMPLETED

Yibin Chinese Medicine Hospital

Yibin, Sichuan, China

Site Status COMPLETED

Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Mingzhen Qin

Role: CONTACT

86-17801222857

Facility Contacts

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Liming Zhang

Role: primary

+86 13845129799

Geng Chang

Role: primary

+86 18098876275

Chengjun Li

Role: primary

+86 13687605150

Mingzhen Qin

Role: primary

8617801222857

Other Identifiers

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2022YFC3501104-01

Identifier Type: -

Identifier Source: org_study_id

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