RANDOMIZED TRIAL OF ORG-10172 IN ACUTE ISCHEMIC STROKE

缺血性中风是导致中国人死亡或残疾的主要神经系统原因 美国。每年，超过40万美国人中风， 这种疾病每年造成的经济损失超过120亿美元。不接受治疗 已被证明在改善急性胰腺炎后的预后方面有效 缺血性中风。不管中风的机制是什么，干预 这将改善临床结果将是有价值的。 肝素是治疗病人最常用的处方药。 患有急性缺血性中风。尽管肝素的使用是侧面的，但其 缺血性卒中的治疗价值仍存在争议。没有审判 已经决定了肝素和NO的有效性或无效性 临床共识是存在的。许多内科医生都很担心它的安全性 因为它可能伴随着潜在的生命威胁 并发症包括出血、血小板减少或动脉 血栓形成。 肝素抗血栓作用与其相互作用的分离 抗凝血剂和血小板聚集性能已在 低分子(LMW)类肝素。这些化合物具有更大的 关于出血的安全边际比肝素更安全，并且不影响 血小板。Org 10172是研究最广泛的低分子肝素。我们的 初步研究表明，组织10172相对安全和良好- 在缺血性中风患者中耐受性。我们确定了一个 潜在的最佳剂量和治疗方案。我们的结果表明 这种治疗还可以降低缺血性中风的死亡率和发病率。 这是一种很有希望的疗法，但其治疗效果也可能会降低。 缺血性卒中的死亡率和发病率。这是一种很有前途的疗法，但 其治疗急性缺血性卒中的疗效尚未得到证实。 测试组织10172的疗效将需要一项随机临床试验。 我们建议进行一项随机、双盲、安慰剂对照的临床试验。 在急性脑缺血24小时内治疗的1,300名患者中的10172名 美国有20个中风中心。患者将接受7个月的治疗 天数和答复将在7天和3个月内使用 格拉斯哥结果量表和Barthel指数。这项试验的设计使所有人 安全系数得到了充分的评估。这项试验没有测试任何 缺血性中风的可能机制或不良结局的原因， 相反，我们正在测试医疗干预是否提供了任何临床 造福于患者。这项试验的目的是检测一项进步 使用意向治疗，治疗效果好的30% 阿尔法为0.05，贝塔为0.90的分析。

Ischemic stoke is the leading neurologic cause of death or disability in the United States. Annually, more than 400,00 Americans have a stroke and the economic costs of this illness exceed $12 billion yearly. No treatment has been demonstrated to be effective in improving outcome after acute ischemic stroke. Regardless of the mechanisms of stroke, an intervention that improves clinical outcome will be valuable. Heparin is the most frequently prescribed drug for treatment of patients with acute ischemic stroke. Despite the sidespread use of heparin, its value in the management of ischemic stroke remains controversial. No trial has determined either the efficacy or lack of usefulness of heparin and no clinical consensus exists. Many physicians are concerned about the safety of heparin because it can be accompanied by potentially life-threatening complications including hemorrhage, thrombocytopenia or arterial thrombosis. Dissociation of the antithrombotic effects of heparin from its anticoagulant and platelet aggregating properties has been achieved in the low molecular weight (LMW) heparinoids. These compounds have a greater margin of safety in regards to bleeding than does heparin and do not affect platelets. Org 10172 is the most extensively studied LMW heparinoid. Our pilot studies have a shown that Org 10172 is relatively safe and well- tolerated in patients with ischemic stroke. We have determined a potentially optimal dosage and treatment regimen. Our results suggest that this treatment may also reduce mortality and morbidity of ischemic stroke. It is a promising therapy but its efficacy for treatment may also reduce mortality and morbidity of ischemic stroke. It is a promising therapy but its efficacy for treatment of acute ischemic stroke has not been proved. Testing the efficacy of Org 10172 will require a randomized clinical trial. We propose a randomized, double-blind, placebo-controlled, clinical trial of Org 10172 in 1300 patients treated within 24 hours of acute ischemic stroke in 20 centers in the United States. Patients will be treated for 7 days and responses will be determined at 7 days and 3 months using the Glasgow Outcome Scale and Barthel Index. The trial is so designed that all safety factors are adequately evaluated. This trial is not testing any putative mechanism of ischemic stroke or reasons for unfavorable outcomes, rather we are testing whether a medical intervention provides any clinical benefit to patients. This trial has been designed to detect an improvement in favorable outcome by 30% with treatment, using intention-to-treat analyses with an alpha of 0.05 and beta of 0.90.