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首页> 外文期刊>Archives of Neurology >Argatroban tPA stroke study: study design and results in the first treated cohort.
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Argatroban tPA stroke study: study design and results in the first treated cohort.

机译：Argatroban tPA中风研究:研究设计结果治疗组。

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BACKGROUND: The benefit of intravenous recombinant tissue plasminogen activator (rtPA) in acute stroke is linked to clot lysis and artery recanalization. Argatroban is a direct thrombin inhibitor that safely augments the benefit of rtPA in animal stroke models. There are no human data on this combination. DESIGN: We report the first phase of the Argatroban tPA Stroke Study, an ongoing prospective, open-label, dose-escalation, safety and activity study of argatroban and rtPA in patients with ischemic stroke. The primary outcome was incidence of intracerebral hemorrhage; secondary outcome, complete recanalization at 2 hours. After standard-dose intravenous rtPA administration, a 100-mug/kg bolus of argatroban followed by infusion of 1 mug/kg per minute for 48 hours was adjusted to a target partial thromboplastin time of 1.75 times that of the control group. RESULTS: Fifteen patients (including 10 men) were enrolled, with a mean +/- SD age of 61 +/- 13 years. All patients had middle cerebral artery occlusions. Baseline median National Institute of Health Stroke Scale score was 14 (range, 4-25). The mean +/- SD time from symptom onset to argatroban bolus administration was 172 +/- 53 minutes. Symptomatic intracerebral hemorrhage occurred in 2 patients, including 1 with parenchymal hemorrhage type 2. Asymptomatic bleeding occurred in 1 patient and there was 1 death. Recanalization was complete in 6 patients and partial in another 4, and reocclusion occurred in 3 within 2 hours of rtPA bolus administration. CONCLUSION: The safety of low-dose argatroban combined with intravenous rtPA may be within acceptable limits, and its efficacy for producing fast and complete recanalization is promising, but a larger cohort of patients is required to confirm these preliminary observations.
机译：背景:静脉注射重组的好处组织纤溶酶原激活物(rtPA)在急性中风与血栓溶解和动脉血管再通。抑制剂,安全增强的好处rtPA中风动物模型。这种组合的数据。第一阶段Argatroban tPA中风的研究中,一个正在进行的前瞻性、非盲、剂量、安全性和活动的研究argatroban和rtPA缺血性患者中风。脑出血;在2小时内完成血管再通。标准剂量静脉rtPA管理100 -杯/公斤丸argatroban紧随其后注入1杯/公斤每分钟48小时调整到目标局部血栓形成质是对照组的1.75倍。15例患者(包括10人)了,意思是+ / - SD 61 + / - 13岁年。遮挡。健康中风量表评分14岁(范围、4-25)。均值+ / - SD从症状出现的时间argatroban丸政府172 + / - 53分钟。发生在2例,其中包括1实质出血2型。出血发生在病人有1死亡。在另一个4部分,reocclusion发生在3 rtPA丸后2小时内管理。低剂量argatroban结合静脉rtPA可能在可接受的范围内,它的生产快速和完整的功效血管再通是有前途的,但一个更大的群体病人需要确认这些初步观察。

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