比较泰毕全® 和阿司匹林治疗不明原因栓塞性卒中（ESUS）的试验结果发表在《新英格兰医学杂志》上1
- 第一项比较达比加群与阿司匹林的III期、随机临床试验
- 两款药物在预防不明原因栓塞性卒中后复发性卒中方面无显著性差异
- 达比加群与阿司匹林相比，在大出血方面无显著性差异
德国殷格翰，5月16日 - 勃林格殷格翰今天公布了RE-SPECT ESUS®试验的完整结果，这是一项比较泰毕全®（达比加群酯）与阿司匹林（ASA）在不明原因栓塞性卒中（ESUS）患者中预防复发性卒中的疗效和安全性的、随机、双盲III期研究。研究结果已发表在《新英格兰医学杂志》上。
该试验未达到主要终点，即未显示达比加群与阿司匹林在降低不明原因栓塞性卒中患者卒中复发风险方面存在有临床意义的差异。但是，一项事后分析显示，在治疗一年后观察到有利于达比加群的疗效趋势。1该临床试验在安全性方面的结果表明，达比加群与阿司匹林在大出血风险方面没有显著性差异。1两种药物在颅内出血等最严重出血结局方面显示了相当的低风险。1
这是全球首个比较达比加群与阿司匹林的临床试验，研究结果进一步丰富了达比加群的安全性证据，为其广泛全面的RE-VOLUTION® 临床试验以及注册研究中已证实的安全性特征再添新证。2-24
“RE-SPECT ESUS研究的结果提供了非常有趣的信息。该研究结果显示，在发生过卒中的高风险人群中，达比加群大出血风险较低，与阿司匹林相似。这再一次明确证实了达比加群有利的风险获益比。”勃林格殷格翰公司副总裁，心血管及代谢领域医学负责人Waheed Jamal博士说道。
不明原因栓塞性卒中属于隐源性卒中的一种类型，缺血性卒中的原因不明且排除其他潜在诊断的情况下归于此类。25, 26 从总体上看，有六分之一的缺血性卒中属于不明原因栓塞性卒中类型。25 发生不明原因栓塞性卒中之后，大多数患者均接受阿司匹林等抗血小板治疗27； 但仍然有三分之一的患者会在五年内出现卒中复发。28
泰毕全尚未在任何国家获批用于ESUS患者。
德国埃森大学医院神经科
临床神经科学高级教授
Hans-Christoph Diener
美国南佛罗里达州大学
血管神经病学教授
David Z. Rose
关于RE-SPECT ESUS®临床试验
在不明原因栓塞性卒中患者中比较口服凝血酶抑制剂达比加群与阿司匹林（ASA）在卒中二级预防方面的疗效和安全性的随机、双盲研究（RE-SPECT ESUS®）1
RE-SPECT ESUS®是一项在不明原因栓塞性卒中患者中比较达比加群与阿司匹林在卒中二级预防方面的III期、双盲临床试验，此试验从40多个国家招募5,390名患者。患者随机接受以下两种治疗方式其中之一：
- 达比加群150 mg每日两次治疗（年龄在75岁以上或者有肾功能损害的患者可调整至110 mg每日两次），和匹配阿司匹林100 mg的安慰剂治疗；
- 阿司匹林100 mg，和匹配达比加群的安慰剂治疗。
本临床试验的主要终点为显示达比加群与阿司匹林对于预防不明原因栓塞性卒中患者卒中复发风险存在有临床意义的差异。1
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