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

Study Overview
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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.

Official Title
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Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice: A Patient Registry

Conditions
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Ischemic Stroke, Acute

Intervention / Treatment
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* Drug: Shuxuetong Injection


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposure group<br>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<br>* According to clinical real treatment records<br>|
| Non-exposure group<br>The non-exposed group was defined as patients receiving guideline-standardized treatment after intravenous alteplase or tenecteplase. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shuxuetong Injection, Intravenous Thrombolysis, Patient Registry