Albumin in Acute Stroke (ALIAS) Trial Statistical and Data Coordinating Center

描述（由申请方提供）：正在进行的白蛋白治疗急性卒中（ALIAS）第2部分试验是一项多中心、随机化、双盲、安慰剂对照III期试验，旨在确定2 g/kg剂量的25%白蛋白（ALB）治疗急性缺血性卒中（AIS）患者的有效性，这些患者的基线NIHSS评分为6，并且可以在卒中发作后5小时内接受研究药物治疗。具体而言，我们希望确定与安慰剂（生理盐水）治疗相比，ALB治疗是否增加了具有良好结局的AIS患者比例。有利结局定义为在随机化后3个月测量的NIH卒中量表（NIHSS）评分为0或1，或改良兰金量表（mRS）评分为0或1，或两者均为。该试验目前由两个NINDS合作协议资助赠款资助迈阿密大学的临床协调中心（PI：Myron D. Ginsberg，MD）和南卡罗来纳州医科大学的统计和数据协调中心（SDCC）（PI：Yuko Y. Palesch，PhD）。ALIAS第2部分试验遵循招募了434例受试者的第1部分试验。它是对第1部分方案进行一些重大修改以更好地确保受试者安全性的结果。迄今为止，第2部分试验已入组了1，100例受试者中的357例，这些受试者需要以约90%的把握度检测ALB治疗组相对于生理盐水治疗组的有利结局比例增加10%。目前，北美约有70家临床研究中心参与了该试验。 SDCC的竞争性续期申请旨在成功完成ALIAS第2部分试验。(The CCC的竞争性更新申请已于2010年7月提交，目前正在审查中。）SDCC的目标是继续与临床研究者合作，通过提供可靠有效的数据和项目管理促进试验的实施，并将我们的统计专业知识应用于试验数据的分析。此外，在下一个资助期内，我们亦计划专注于开发新的统计方法及/或修改现有方法，以解决试验所产生的统计问题。

DESCRIPTION (provided by applicant): The ongoing Albumin in Acute Stroke (ALIAS) Part 2 Trial is a multicenter, randomized, double- blinded, placebo-controlled Phase III trial to ascertain the effectiveness of 2 g/kg dose of 25% albumin (ALB) therapy in patients with acute ischemic stroke (AIS) whose baseline NIHSS score is 6 and who can be treated with study drug within 5 hours of stroke onset. Specifically, we wish to determine whether ALB therapy increases the proportion of AIS patients with favorable outcome compared to placebo (saline) therapy. Favorable outcome is defined as either an NIH Stroke Scale (NIHSS) score of 0 or 1, or a modified Rankin Scale (mRS) score of 0 or 1, or both, measured at 3 months from randomization. The Trial currently is supported by two NINDS cooperative agreement grants to the Clinical Coordinating Center at the University of Miami (PI: Myron D. Ginsberg, MD) and the Statistical and Data Coordination Center (SDCC) at the Medical University of South Carolina (PI: Yuko Y. Palesch, PhD). The ALIAS Part 2 Trial follows the Part 1 Trial that recruited 434 subjects. It arose as a result of some major modifications to the Part 1 protocol to better ensure subject safety. To date, the Part 2 Trial has enrolled 357 out of 1,100 subjects needed to detect with approximately 90% power a 10% increase in the proportion of favorable outcome in the ALB therapy group relative to saline therapy group. Approximately 70 clinical sites throughout North America are currently participating in the Trial. The purpose of this competitive renewal application from the SDCC is to bring the ALIAS Part 2 Trial to successful completion. (The competitive renewal application from the CCC was submitted in July 2010 and is under review at this writing.) The aims of the SDCC are to continue to collaborate with the clinical investigators to facilitate the implementation of the Trial by providing reliable and efficient data and project management, and to apply our statistical expertise to the analysis of the Trial data. Furthermore, in the next grant period, we also plan to focus on the development of new statistical methods and/or modification of existing methods to address the statistical issues arising from the Trial.