DIAS (Desmoteplase in Acute Ischemic Stroke)
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Desmoteplase in Acute Ischemic Stroke (DIAS)

Registry of Trials clinicaltrials.gov
Year 2001
連結 Registry of Trials

This article is not included in any systematic review

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The DIAS study (Part 2) was performed to support the dose finding of desmoteplase treatment in subjects with acute ischemic stroke selected by perfusion/diffusion mismatch on MRI within a time window of 3 to 9 h after stroke-symptom onset. In addition, it assessed safety and tolerability of 3 doses of desmoteplase compared with placebo with special consideration of intracranial hemorrhage and major systemic bleedings.

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The DIAS study: results of a phase II, MRI-based dose finding study of desmoteplase in acute stroke

作者 Hacke, W
會議 XVIIth International Congress on Fibrinolysis and Proteolysis Melbourne, Australia 21 - 25 March,
Year 2004
連結 www.med.monash.edu.au

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BACKGROUND: Thrombolytic therapy with i.v. rt-PA in a 3h time window is so far the only approved therapy of acute ischemic stroke. However, the majority of patients arrive after 3h of stroke onset in the hospital representing a clear unmet medical need. Desmoteplase (DSPA) is a highly fibrin specific plasminogen activator with a long terminal half-life, lack of neurotoxicity, and due to some distinct pharmacological properties may have a good safety profile especially in the elderly. METHODS: The DIAS (Desmoteplase In Acute ischaemic Stroke) trial, a placebo controlled, double blind, international, dose finding phase II study, randomized 104 acute ischemic stroke patients. Patients scoring 4-20 on NIHSS, presenting a PWI/DWI mismatch on MRI and eligible to be treated 3-9h after stroke onset were selected. DSPA or placebo was administered as i.v. bolus. Safety endpoints included the rate of symptomatic intracerebral hemorrhage (sICH). Efficacy endpoints were the rate of reperfusion (measured by a reduction of the PWI deficit >/= 30% or a reopening of the affected vessel 4-8h after treatment) and clinical outcome (reduction by >/= 8 points or scoring 0-1 on NIHSS, mRS 0-2 and BI 100-75). The first part of the DIAS trial investigated fixed doses (25, 37.5 and 50 mg) of DSPA vs placebo in 47 patients. In the second part (n=57), DSPA doses were adjusted to body weight and lowered: 62.5, 90 and 125 µg/kg BW. RESULTS: All treatment groups were generally balanced with regard to their baseline parameters. The first part of the study was terminated prematurely, because the predefined threshold for sICH was exceeded. In the second part, sICH rates were 0% in the 62.5 µg/kg group, 6.7% in the 90 µg/kg group and 0% in the 125 µg/kg group (overall sICH rate of 2.2%). Reperfusion rates were: Placebo 19.2%, DSPA 62.5 µg/kg 23.1%, 90 µg/kg 46.7%, 125 µg/kg 71.4%, resulting in a linear dose response curve. Clinical outcome at day 30 (day 90 data still blinded) was: Placebo 22.2%, DSPA 62.5 µg/kg 20.0%, 90 µg/kg 20.0% and 125 µg/kg 46.7%. The 125 µg/kg dose group was selected as the target dose for phase III having the best benefit-to-risk ratio.

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去氨普酶在急性缺血性中风试验（DIAS）：9小时的窗口阶段II磁共振静脉去氨普酶急性卒中溶栓试验。

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期刊 Stroke; a journal of cerebral circulation
Year 2005
連結 Pubmed DOI

此文章收錄於 4 Systematic reviews Systematic reviews (4 references)

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背景与目的：大多数急性缺血性中风患者到达后3小时时间窗重组组织型纤溶酶原激活剂（rtPA治疗）管理。去氨普酶治疗急性缺血性中风的审判（DIAS）是一个随机试验，旨在评价其安全性和疗效去氨普酶静脉注射，患者缺血性中风发病3至9小时内给予高度纤维蛋白具体和nonneurotoxic的的血栓溶解剂，剂量调查灌注/扩散MRI上的不匹配。 方法：DIAS的是安慰剂对照，双盲，随机，剂量调查的第二阶段试验。患者与国家健康卒中量表（NIHSS）分数4至20日和MRI灌注/扩散不匹配的证据资格。104例患者中，第47（简称为第1部分）被随机分配到固定剂量的去氨普酶（25毫克，37.5毫克或50毫克）或安慰剂。由于症状性颅内出血（SICH），低体重调整剂量率过高升级通过为62.5微克/公斤，90微克/千克和125微克/公斤，随后在57例（简称第2部分）。的安全性端点的是的Sich的的的的率。疗效终点分别为与后，4至8小时，和的临床的的成果比较，作者：再灌注的MRI上的率，作为由NIHSS评分，改良Rankin的规模，和Barthel指数的的分摊在90天内。 结果：第1部分提前终止因为SICH去氨普酶（26.7％）的高利率。第2部分中，的SICH率为2.2％，。与安慰剂或者部分没有SICH发生。观察去氨普酶（125微克/千克），19.2％，与安慰剂相比，再通率高达71.4％（P = 0.0012）。有利的90天临床结果发现在安慰剂治疗的患者的22.2％和13.3％之间（62.5微克/千克，P = 0.757）和60.0％（125微克/公斤，P = 0.0090）去氨普酶治疗的患者。早期的再灌注相关性毫不逊色与临床结果（，P = 0.0028）。有利的结果发生在52.5％与24.6％的患者没有再灌注缺血再灌注患者的经历。 结论：急性缺血性中风患者灌注/扩散不匹配选择3至9个小时后给予静脉去氨普酶具有较高的再灌注率和较好的临床疗效与安慰剂相比。SICH去氨普酶率为低，使用剂量为125微克/千克。