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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke, Acute
• Intervention / Treatment: Drug: Shuxuetong Injection

• Study Type: Observational
• Enrollment (Actual): 2408

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Beijing Royal Integrative Medicine Hospital
    • Beijing, Beijing Municipality, China
      • China Aerospace Science and Industry Corporation 731 Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • Chongqing Chinese Medicine Hospital
    • Chongqing, Chongqing Municipality, China
      • University-Town Hospital of Chongqing Medical University
  • Guangxi
    • Nanning, Guangxi, China
      • Nanning First People's Hospital
  • Guizhou
    • Guiyang, Guizhou, China
      • Guizhou People's Hospital
  • Hebei
    • Cangzhou, Hebei, China
      • Hebei CangZhou Hospital of Integrated Traditional Chinese and Western Medicine
    • Tangshan, Hebei, China
      • Tangshan Central Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • The Second Affiliated Hospital of Harbin Medical University
    • Harbin, Heilongjiang, China
      • The First Affiliated Hospital of Harbin Medical University
    • Mudanjiang, Heilongjiang, China
      • Hongqi Hospital Affiliated to Mudanjiang Medical University
  • Henan
    • Anyang, Henan, China
      • Anyang Third People's Hospital
    • Anyang, Henan, China
      • Huaxian People's Hospital
    • Anyang, Henan, China
      • Neihuang People's Hospital
    • Jiaozuo, Henan, China
      • Jiaozuo Second People's Hospital
    • Kaifeng, Henan, China
      • Kaifeng People's Hospital
    • Luohe, Henan, China
      • Luohe Sixth People's Hospital
    • Nanyang, Henan, China
      • Nanyang Nanshi Hospital
    • Pingdingshan, Henan, China
      • Ye County People's Hospital
    • Pingdingshan, Henan, China
      • Baofeng Chinese Medicine Hospital
    • Pingdingshan, Henan, China
      • Baofeng People's Hospital
    • Pingdingshan, Henan, China
      • Pingdingshan First People's Hospital
    • Shangqiu, Henan, China
      • Shangqiu Municipal Hospital
    • Xinxiang, Henan, China
      • Xinxiang Central Hospital
    • Xinxiang, Henan, China
      • The First Affiliated Hospital of Xinxiang Medical University
    • Xinxiang, Henan, China
      • Xinxiang First People's Hospital
    • Xinxiang, Henan, China
      • Changyuan Chinese Medicine Hospital
    • Xinyang, Henan, China
      • Xi County Central Hospital
    • Zhengzhou, Henan, China
      • the First Affiliated Hospital of Henan University of Chinese Medicine
    • Zhumadian, Henan, China
      • Runan People's Hospital
  • Hunan
    • Changsha, Hunan, China
      • Changsha First Hospital
    • Changsha, Hunan, China
      • The Affiliated Hospital of Hunan Academy of Chinese Medicine
    • Luoyang, Hunan, China
      • The First Affiliated Hospital of Henan University of Science & Technology
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing Chinese Medicine Hospital
    • Nantong, Jiangsu, China
      • Affiliated Hospital of Nantong University
    • Pengzhou, Jiangsu, China
      • Pengzhou Chinese Medicine Hospital
    • Yancheng, Jiangsu, China
      • Yancheng First People's Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Gaoxin Hospital Of The First Affiliated Hospital Of Nanchang University
    • Nanchang, Jiangxi, China
      • Jiangxi People's Hospital
  • Jilin
    • Jilin, Jilin, China
      • Jilin Central General Hospital
    • Songyuan, Jilin, China
      • Songyuan Jilin Oifield Hospital
  • Liaoning
    • Anshan, Liaoning, China
      • Anshan Central 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
      • Dalian University Affiliated Xinhua Hospital
    • Dalian, Liaoning, China
      • 967 Hospital of The Joint Logistics Support Force of PLA
    • Dalian, Liaoning, China
      • Central Hospital Affiliated Dalian University of Technology
    • Jinzhou, Liaoning, China
      • Jinzhou Central Hospital
    • Shenyang, Liaoning, China
      • The First Hospital of China Medical University
    • Shenyang, Liaoning, China
      • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
    • Tieling, Liaoning, China
      • Tieling Central Hospital
  • Shandong
    • Binzhou, Shandong, China
      • Binzhou Medical University Hospital/ The First School of Clinical Medicine of Binzhou Medical University
    • Jinan, Shandong, China
      • The Second Hospital of Shandong University
    • Jinan, Shandong, China
      • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
    • Liaocheng, Shandong, China
      • Liaocheng Third People's Hospital
    • Linyi, Shandong, China
      • Linyi Hospital of Traditional Chinese Medicine
    • Ningjin, Shandong, China
      • Ningjin People's Hospital
    • Qingdao, Shandong, China
      • Qingdao Huangdao District Chinese Medicine Hospital
    • Weihai, Shandong, China
      • Weihai Wendeng District People's Hospital
    • Zibo, Shandong, China
      • Zibo Hospital of Traditional Chinese Medicine
    • Zibo, Shandong, China
      • Zibo First Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Shanghai Pingdingshan Hospital of Traditional Chinese Medicine
  • Shanxi
    • Changzhi, Shanxi, China
      • Affiliated Hospital Of Changzhi Institute Of TCM
    • Taiyuan, Shanxi, China
      • Gujiao Central Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • Chengdu Seventh People's Hospital
    • Chengdu, Sichuan, China
      • Chengdu Integrated TCM & Western Medicine 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
    • Luzhou, Sichuan, China
      • Xuyong Chinese Medicine Hospital
    • Meishan, Sichuan, China
      • Qingshen People's Hospital
    • Mianyang, Sichuan, China
      • Mianyang Third People's Hospital
    • Nanchong, Sichuan, China
      • Nanchong Central Hospital
    • Panzhihua, Sichuan, China
      • Panzhihua Central Hospital
    • Yibin, Sichuan, China
      • Yibin Chinese Medicine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute ischemic stroke who received alteplase or tenecteplase within 4.5 hours of onset

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Shuxuetong Injection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of mRS (0-1)	The modified Rankin Scale (mRS) score ranges from 0 (best score) to 6 (worst score).	90±7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	baseline, 14 days or the day of discharge
BI	The Barthel Index (BI) score ranges from 0 (worst score) to 100 (best score).	90±7 days
Total mortality	The occurrence of mortality of any cause within 90 days.	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.	Within 90 days

Collaborators and Investigators

• Sponsor: Dongzhimen Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2023
• Primary Completion (Actual): August 28, 2025
• Study Completion (Actual): September 3, 2025

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Patient Registry; Intravenous Thrombolysis; Shuxuetong Injection
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; shuxuetong
• Other Study ID Numbers: 2022YFC3501104-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No