Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China a Real-world, Multicenter, Retrospective, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Rate of patients with symptomatic intracranial hemorrhage within 36 hours
研究概览
简要总结
The objective of the study is to investigate the effectiveness and safety of rhTNK-tPA in acute ischemic stroke patients within 4.5 hours of symptom onset in a real-world clinical setting.
详细描述
Recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) has the logistic advantage of a single bolus infusion over recombinant tissue plasminogen activator (rt-PA) which needs a 1-hour infusion. The non-inferiority of rhTNK-tPA compared to rt-PA was proved by two recent randomized controlled clinical trials but the evidence is lacking regarding the real-world effectiveness and safety of rhTNK-tPA.
This is a multi-center, observational, retrospective study that enrolled acute ischemic stroke patients treated with rhTNK-tPA thrombolysis in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all acute ischaemic stroke patients who met eligibility for thrombolysis with intravenous alteplase or TNK and presenting within 4·5 hours of symptom onset.
排除标准
- •variables with a missing rate > 40%
研究组 & 干预措施
Tenecteplase
acute ischemic stroke patients who receive intravenous thrombolysis with tenecteplase
干预措施: Tenecteplase (Drug)
alteplase
acute ischemic stroke patients who receive intravenous thrombolysis with alteplase
干预措施: Alteplase (Drug)
结局指标
主要结局
Rate of patients with symptomatic intracranial hemorrhage within 36 hours
时间窗: 36 hours
Clinical deterioration or neurological decline causing an increase in NIHSS score of ≥4 points due to intracranial hemorrhage confirmed by brain imaging
次要结局
- discharge NIHSS score(at discharge (up to 30 days))
- discharge mRS(at discharge (up to 30 days))
- 24 hours NIHSS score(at 24 hours after receiving thrombolysis)
- Rate of patients with any intracranial hemorrhage(during hospital stay (up to 30 days))
- 90 days mRS 0-1(at 90±7 days)
- 90 days mRS shift(at 90±7 days)
- Rate of patients with any systematic bleeding(during hospital stay (up to 30 days))
- Rate of patients with 90 days mortality(at 90±7 days)