Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice: A Patient Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,008
- 试验地点
- 78
- 主要终点
- Proportion of mRS (0-1)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Shuxuetong Injection (Drug)
结局指标
主要结局
Proportion of mRS (0-1)
时间窗: 90±7 days
The modified Rankin Scale (mRS) score ranges from 0 (best score) to 6 (worst score).
次要结局
- 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)
研究者
Ying Gao
MD, PhD
Dongzhimen Hospital, Beijing