泰毕全®: 首个将在脑静脉血栓或脑静脉窦血栓患者中开展前瞻性研究的NOAC

  • RE-SPECT CVT® 是一项研究达比加群酯（泰毕全 ® ）与华法林比较治疗脑静脉血栓（ CVT ） 1 患者的 III 期研究
  • 研究结果将有助于医生选择合适的、用于急性治疗和二级预防脑静脉或脑静脉窦血栓的口服抗凝剂 1

勃林格殷格翰将开展使用非维生素K拮抗剂口服抗凝药（NOAC）治疗脑静脉血栓或脑静脉窦血栓患者的首项前瞻性、随机化对照研究。RE-SPECT CVT®将研究达比加群酯（泰毕全®）与华法林相比，在急性治疗和二级预防脑静脉血栓（CVT）方面的安全性和疗效。在西班牙巴塞罗那召开的第二届2016年欧洲卒中组织大会上宣布了本项新研究。1

当脑静脉或脑静脉窦（大脑排出血液的通道）中形成血栓时，会发生脑静脉血栓（CVT）。如果这些静脉或通道堵塞，血液将滞留于大脑中。将会造成颅内血压升高、脑组织血管充血和渗血，并最终导致出血性脑卒中。2

尽管CVT相对罕见，但是一旦发生，需立即进行药物治疗，并且可能导致严重的长期并发症。2目前，关于急性CVT治疗和二级预防复发血栓的标准疗法包括利用普通肝素或低分子量肝素进行抗凝治疗，随后利用维生素K拮抗剂（VKA–华法林）进行治疗。1现已证明，达比加群酯可有效治疗和预防其它类型血栓，与VKA治疗相比，具备更有利的安全性特征。3-7RE-SPECT CVT®研究将考察达比加群酯是否也能为CVT患者提供治疗获益。1

“我们对本项新研究感到非常激动。CVT患者需获得有效治疗，并且我们相信他们将从抗凝治疗近期取得的进展中获益良多”， 来自葡萄牙里斯本圣玛利亚医院，神经科学和心理健康科的José M. Ferro教授表示。“RE-SPECT CVT®研究将为医生提供更多的知识以解决该适应证未被满足的医疗需求”。

RE-SPECT CVT®研究是勃林格殷格翰在抗凝领域创新的最新组成部分。由勃林格殷格翰研发的达比加群酯，是首个用于预防房颤患者发生脑卒中的NOAC，8并且，idarucizumab于2015年获批成为可用于紧急情况（当需要立即逆转达比加群的抗凝效果时）的首个唯一的NOAC特异性拮抗剂。9

RE-SPECT CVT®研究简介

在脑静脉血栓患者中比较达比加群酯与剂量调整的华法林的安全性和疗效的随机化评估（RE-SPECT CVT®）1

RE-SPECT CVT®是一项在脑静脉血栓（CVT）患者中评估达比加群酯（泰毕全®） 的安全性和疗效的前瞻性、随机化III期研究。该开放标签研究将在欧洲和加拿大招募180例患者，以确定达比加群酯与华法林（INR 2-3）相比，治疗和二级预防脑静脉或脑静脉窦血栓的适宜性。将对18岁及以上并确诊为CVT的患者（伴或不伴出血性脑卒中）随机分配给予华法林或达比加 群酯治疗。1计划于2019年公布研究结果。10

更多信息

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