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抗血小板治疗联合 rt-PA 溶栓治疗缺血性脑卒中(ARTIS):一项随机对照试验的原理和设计。

Antiplatelet therapy in combination with rt-PA thrombolysis in ischemic stroke (ARTIS): rationale and design of a randomized controlled trial.

机构信息

Department of Neurology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.

出版信息

Cerebrovasc Dis. 2010;29(1):79-81. doi: 10.1159/000256651. Epub 2009 Nov 10.

DOI:10.1159/000256651
PMID:19907167
Abstract

BACKGROUND

Thrombolysis with recombinant tissue plasminogen activator (rt-PA) is currently the only approved acute therapy for ischemic stroke. After rt-PA-induced recanalization, reocclusion is observed in 20-34%, probably caused by platelet activation. In acute myocardial infarction, the combination of thrombolytic and antiplatelet therapy leads to a better outcome compared to thrombolytic treatment alone. In patients with acute ischemic stroke, several studies showed that those on antiplatelet treatment prior to rt-PA had an equal or even better outcome compared to patients without prior use of antiplatelet therapy, despite an increased risk of bleeding.

METHODS

We present the protocol of a multicenter randomized clinical trial (n = 800) investigating the effects of immediate addition of aspirin to rt-PA on poor outcome (modified Rankin score >2) in ischemic stroke patients.

CONCLUSION

This study will answer the question whether the combination of rt-PA and antiplatelet therapy improves the functional outcome in ischemic stroke patients.

摘要

背景

重组组织型纤溶酶原激活剂(rt-PA)溶栓是目前治疗缺血性脑卒中唯一被批准的急性治疗方法。rt-PA 诱导再通后,约 20-34%的患者会出现再闭塞,可能是由血小板激活引起的。在急性心肌梗死中,溶栓联合抗血小板治疗比单独溶栓治疗的效果更好。在急性缺血性脑卒中患者中,几项研究表明,与未使用抗血小板治疗的患者相比,rt-PA 治疗前使用抗血小板治疗的患者结局相当甚至更好,尽管出血风险增加。

方法

我们介绍了一项多中心随机临床试验(n=800)的方案,该试验旨在研究在缺血性脑卒中患者中,立即将阿司匹林加用至 rt-PA 是否会改善预后不良(改良 Rankin 评分>2)。

结论

这项研究将回答 rt-PA 和抗血小板治疗联合应用是否能改善缺血性脑卒中患者的功能结局这一问题。

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