Design of the trial of Org 10172 in acute stroke treatment (TOAST)

Design of the trial of Org 10172 in acute stroke treatment (TOAST)
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DOI:
10.1016/s0197-2456(97)00012-3
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发表时间:
1997-08-01
期刊:
CONTROLLED CLINICAL TRIALS
影响因子:
--
通讯作者:
Grimsman, KJ
Grimsman, KJ
中科院分区:
其他
文献类型:
--
作者:
Adams, HP;Woolson, RF;Grimsman, KJ

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吐司是一项多中心、随机、安慰剂对照的临床试验,旨在检测一种新型抗血栓药物在改善急性缺血性卒中患者预后方面的有效性。直到最近,还没有临床试验测试缺血性卒中的治疗方法在结果上显示出有效性。以前进行的试验的设计问题与不确定的结果可能部分解释他们的失败。在吐司的设计过程中,研究人员解决了几个问题,因此试验可以准确地测试治疗。我们报告了在设计、实施和协调试验中使用的策略。(C)Elsevier Science Inc. 1997.
TOAST is a multicenter, randomized, placebo-controlled clinical trial testing the usefulness of a new antithrombotic drug in improving the outcome of persons with acute ischemic stroke. Until recently, no clinical trial testing a treatment for ischemic stroke had demonstrated efficacy in outcome. Design problems of previously conducted trials with inconclusive results may partly explain their failures. During the design of TOAST, the investigators addressed several issues so the trial could test the treatment accurately. We report the strategies used in designing, implementing, and coordinating the trial. (C) Elsevier Science Inc. 1997.