RANDOMIZED TRIAL OF ORG 10172 IN ACUTE ISCHEMIC STROKE

这是一个大型多中心、双中心的续展申请 采用意向治疗分析的盲法、安慰剂对照试验 正在测试含有非肝素的硫酸盐混合物的能力 糖胺葡聚糖(类肝素/达那洛尔/组织10172)改善 急性缺血性卒中患者的重要结局事件。这 试验已得到赠款5-R0-1-NS-27863-02的资助，目前正在 与R.F.Woolson继续提交的提案一起提交(5- R0-L-NS-27960-01)。这两项提案旨在联合审查。这个 在本试验中检验的主要假设是组织10172在 与传统医疗护理相结合优于相结合。 常规医疗护理和安慰剂的作用 卒中后三个月预后良好。 抗血栓药物已用于患者的早期治疗 有超过50年的急性缺血性中风。这些药物是用来 预防再发血栓、血栓形成或失败 侧支循环。这些药物也可能是一个重要的辅助手段。 去接受溶栓治疗。尽管它们被广泛使用，但仍然有 关于它们的有效性和安全性，有相当大的争议。这场争议 很大程度上是因为缺乏任何支持这些指征的数据 或这些药物的禁忌症。肝素被复杂化了 严重的出血性副作用和血小板减少。低分子 重量较大的抗血栓药物，如Org 10172可能比 常规肝素。组织10172被用来预防静脉 治疗血栓和治疗肝素引起的血小板减少症。试点研究 OGG 10172在急性缺血性中风患者中的应用前景看好 这些数据被用来开发目前正在进行的试验。 这项精心设计和进行的试验于1990年1月获得资助。 到目前为止，调查人员已经招募了650多名 计划在26个参与中心举行1300次会议。审判已经进行了 成功招募妇女和少数族裔作为本次试验的受试者。 这项试验的一些出版物已经出现。这些 论文报告了我们对进行试验的方法的开发和测试 以及一些基线数据。这项试验最近进入了中期研究阶段 分析和我们的NINDS安全和监控委员会授权我们的 持续招募和治疗患者。在我们的时候 中期分析超过99%的预期数据已输入我们的 数据系统。 尽管我们在招聘方面落后了，但部分原因是 长期的监管和行政拖延，我们可以实现我们的目标 来完成这场审判。我们正在请求批准并继续提供资金 来完成这场重要的审判。未来的审判，不太可能 这种大小和范围，将测试急性中风的抗血栓治疗。

This is an application for continuation of a large multi-center, double- blind, placebo-controlled trial, using intention-to-treat analyses, that is testing the ability of the non-heparin containing mixture of sulfated glycosaminoglycurans (heparinoid/danaparolol/Org 10172) to improve important outcome events among patients with acute ischemic stroke. This trial has been funded under grant 5-R0-1-NS-27863-02 and is being submitted in conjunction with the continuing proposal by R.F.Woolson (5- R0-l-NS-27960-01). The two proposals are intended for joint review. The primary hypothesis being tested in this trial is that Org 10172 in conjunction to conventional medical care is superior to the combination of conventional medical care and placebo in improving the likelihood of a favorable outcome at three months after stroke. Antithrombotic drugs have been used in the early management of patients with acute ischemic stroke for more than 50 years. The drugs were given to prevent recurrent embolism, progression of a thrombosis, or failure of collateral circulation. These drugs may also be an important adjunct to thrombolytic therapy. Despite their widespread use, there is still considerable controversy about their efficacy and safety. The controversy largely results from the absence of any data that support the indications or contraindications for these drugs. Heparin has been complicated by serious hemorrhagic side effects and thrombocytopenia. Low molecular weight antithrombotic drugs such as Org 10172 may be safer than conventional heparin. Org 10172 is being used to prevent venous thromboses and to treat heparin-induced thrombocytopenia. Pilot studies of Org 10172 in patients with acute ischemic stroke were promising and these data were used to develop the trial that is currently underway. This carefully designed and conducted trial was funded in January, 1990. To date, the investigators have enrolled more than 650 patients of the planned 1300 at the 26 participating centers. The trial has been successful in recruiting women and minorities as subjects in this trial. A number of publications from the trial have already appeared. These papers report our development and testing of methods to conduct the trial and some baseline data. The trial recently had its mid-study interim analysis and our NINDS Safety and Monitoring Committee authorized our continued recruitment and treatment of patients. At the time of our interim analysis more than 99% of expected data had been entered in our data system. Although we are behind in recruitment, partially as the result of prolonged regulatory and administrative delays, we can achieve our goal to complete this trial. We are requesting approval and continued funding to complete this important trial. It is unlikely that future trials, of this size and scope, will test antithrombotic therapy in acute stroke.