Statistical and Data Coordinating Center for ALIAS and IMS 111 Trials

ALIAS 和 IMS 111 试验统计和数据协调中心

• 批准号: 7280859
• 负责人: Yuko Y Palesch
• 金额: $ 134.7万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-15 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7280859
• 关键词: Acute; Albumins; Canada; Clinical Trials; Data Coordinating Center; Dose; Double-Blind Method; Funding; Hour; Human; Ischemic Stroke; Measures; Outcome; Patients; Phase; Phase III Clinical Trials; Placebo Control; Placebos; Primary Health Care; Randomized; Range; Recruitment Activity; Safety; Saline; Score; Specific qualifier value; Standards of Weights and Measures; Stroke; Suggestion; Testing; Time; Toxic effect; United States National Institutes of Health; acute stroke; base; clinical research site; cohort; falls; neuroprotection; pre-clinical; preclinical study

The ALIAS Trial (Albumin In Acute Stroke) is a randomized, double-blind, placebo-controlled, multicenter, Phase III clinical trial of high-dose human albumin (ALB) therapy for neuroprotection in acute ischemic stroke. The Trial builds upon extensive preclinical evidence that high-dose ALB is markedly neuro- protective; and our ongoing NIH-funded Phase I ALB Dose-Escalationand Safety Clinical Trial, which has completed the fifth of the six pre-specified ALB dose-tiers (total of 70 subjects) and has shown that the higher doses can be safely administered without ALB-related toxicity and with strong suggestions of efficacy. Significantly, dose-tier V (1.71 g/kg) falls well within the per-kg dose-range of 1.25-2.50 g/kg shown in preclinical studies to be highly protective; The primary aim of the ALIAS Phase III Trial is to ascertain whether high-dose ALB therapy, compared to saline-placebo, will increase the proportion of favorable outcome in subjects with acute ischemic stroke. To this end, we propose to conduct two separate but concurrently implemented randomized, double-blinded trials of ALB therapy in patients with acute ischemic stroke whose baseline NIH Stroke Scale Score (NIHSSS) is 6 or greater and who can be treated with ALB within 5 hours of stroke-onset. The two trials will be carried out in two cohorts: one that receives standard-of-caretreatment with i.v. tPA; and one that does not receive tPA. Decision regarding tPA therapy is based on the local best standard of care.' The primary hypothesis will be tested separately in each cohort. Favorable outcome is defined as either an NIHSSS of 0 or 1, or a modified Rankin Score (mRS)ofOor 1, or both, measured at 3 months from randomization. The trials will incorporate interim analyses, and a maximum of 1,800 subjects will be recruited at 40 clinical sites in the U.S. and Canada. The ALIAS Trial affords the unique opportunity to apply a preclinically highly effective strategy to treat stroke using a dose and timing that closely replicate the experimental setting in which efficacy was shown.

ALIAS 试验（急性中风中的白蛋白）是一项随机、双盲、安慰剂对照、多中心、 大剂量人白蛋白（ALB）治疗急性缺血神经保护的 III 期临床试验 中风。该试验建立在大量临床前证据的基础上，即高剂量 ALB 具有明显的神经功能障碍。 保护的;以及我们正在进行的由 NIH 资助的 I 期 ALB 剂量递增和安全性临床试验，该试验已 完成了六个预先指定的 ALB 剂量级别中的第五个（总共 70 名受试者），并表明 可以安全地施用更高剂量，而不会产生 ALB 相关毒性，并且强烈建议 功效。值得注意的是，剂量层 V (1.71 g/kg) 完全落在每公斤 1.25-2.50 g/kg 的剂量范围内 临床前研究显示具有高度保护作用； ALIAS III 期试验的主要目的是 确定与盐水安慰剂相比，高剂量 ALB 治疗是否会增加 急性缺血性中风患者的良好结果。为此，我们建议开展两 单独但同时实施的 ALB 治疗患者随机、双盲试验 基线 NIH 卒中量表评分 (NIHSSS) 为 6 或更高且可以接受急性缺血性卒中的患者 中风发作后 5 小时内接受 ALB 治疗。这两项试验将分两组进行：一组是 接受标准的静脉注射护理治疗tPA；一种不接受 tPA。关于的决定 tPA 治疗基于当地最佳护理标准。主要假设将单独进行检验 在每个队列中。有利的结果定义为 NIHSSS 为 0 或 1，或修改后的 Rankin 评分 (mRS) 或 1 或两者，在随机分组后 3 个月时测量。试验将包括临时 分析，并将在美国和加拿大的 40 个临床中心招募最多 1,800 名受试者。 ALIAS 试验提供了独特的机会，应用临床前高效策略来治疗 使用与显示疗效的实验环境非常相似的剂量和时间来治疗中风。