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

Dongzhimen Hospital, Beijing2,408 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

2,408

Conditions

Ischemic Stroke, Acute

Interventions

Shuxuetong InjectionDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (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

Outcomes

Primary Outcomes

Proportion of mRS (0-1)

The modified Rankin Scale (mRS) score ranges from 0 (best score) to 6 (worst score).

Time frame: 90±7 days

Secondary Outcomes

Proportion of mRS (0-2)

Time frame: 90±7 days

Proportion of mRS (0-1) or returning to baseline

Time frame: 90±7 days

Distribution of mRS

Time frame: 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).

Time frame: baseline, 14 days or the day of discharge

The Barthel Index (BI) score ranges from 0 (worst score) to 100 (best score).

Time frame: 90±7 days

Total mortality

The occurrence of mortality of any cause within 90 days.

Time frame: 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.

Time frame: Within 90 days