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

Dongzhimen Hospital, Beijing

Status: Enrolling

Conditions: Ischemic Stroke, Acute

Treatments: Drug: Shuxuetong Injection

Study type: Observational

Funder types: Other

Identifiers

NCT06018181

2022YFC3501104-01

Details and patient eligibility

About

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.

Enrollment: 2,008 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,008 participants in 2 patient groups

Exposure group

Description:

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.

Treatment:

Drug: Shuxuetong Injection

Non-exposure group

Description:

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