Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice: A Patient Registry
Overview
- Phase
- Not Applicable
- Intervention
- Shuxuetong Injection
- Conditions
- Ischemic Stroke, Acute
- Sponsor
- Dongzhimen Hospital, Beijing
- Enrollment
- 2008
- Locations
- 78
- Primary Endpoint
- Proportion of mRS (0-1)
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
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.
Investigators
Ying Gao
MD, PhD
Dongzhimen Hospital, Beijing
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Shuxuetong Injection
Outcomes
Primary Outcomes
Proportion of mRS (0-1)
Time Frame: 90±7 days
The modified Rankin Scale (mRS) score ranges from 0 (best score) to 6 (worst score).
Secondary Outcomes
- Proportion of mRS (0-1) or returning to baseline(90±7 days)
- Proportion of mRS (0-2)(90±7 days)
- Change of NIHSS(baseline, 14 days or the day of discharge)
- BI(90±7 days)
- Distribution of mRS(90±7 days)
- Total mortality(Within 90 days)
- Serious Adverse Events(Within 90 days)