RANDOMIZED TRIAL OF ORG-10172 IN ACUTE ISCHEMIC STROKE

缺血性斯托克是导致死亡或残疾的主要神经系统原因， 美国的 每年有超过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。 无治疗 已被证明可有效改善急性 缺血性中风 不管中风的机制如何， 能改善临床效果的方法是很有价值的 肝素是治疗患者最常用的处方药 急性缺血性中风 尽管肝素的广泛使用， 在缺血性卒中治疗中的价值仍存在争议。 没有审判 已经确定了肝素的有效性或缺乏有效性， 临床共识存在。 许多医生担心 因为它可能伴随着潜在的危及生命的 并发症，包括出血、血小板减少症或动脉 血栓形成 肝素的抗血栓作用与其自身的分离 抗凝血和血小板聚集特性已经在 低分子量（LMW）类肝素。 这些化合物具有更大的 在出血方面的安全边际比肝素高，并且不影响 血小板 LMW10172是研究最广泛的LMW类肝素。 我们 初步研究表明，10172是相对安全和良好的， 在缺血性卒中患者中耐受。 我们已经确定了 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。 它是一种有前途的治疗方法，但其治疗效果也可能降低 缺血性卒中的死亡率和发病率。 这是一种很有前途的疗法， 其治疗急性缺血性中风的疗效尚未得到证实。 要测试P10172的疗效，需要进行随机临床试验。 我们提出了一个随机、双盲、安慰剂对照的临床试验 在急性缺血性脑卒中24小时内接受治疗的1300例患者中， 在美国的20个中心。 患者将接受7次治疗 在第7天和第3个月时，将使用 格拉斯哥预后量表和Barthel指数。 审判的设计是为了 充分评估安全因素。 这次审判并不是在测试 缺血性卒中的假定机制或不利结局的原因， 相反，我们正在测试医疗干预是否提供任何临床 对患者有益。 这项试验旨在检测 使用意向性治疗， α为0.05，β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.