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-Escalation and 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-care treatment 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) of 0 or 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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01NS040406-08S1
Application #
8073805
Study Section
National Institute of Neurological Disorders and Stroke Initial Review Group (NSD)
Program Officer
Conwit, Robin
Project Start
2000-07-01
Project End
2011-05-31
Budget Start
2009-06-01
Budget End
2011-05-31
Support Year
8
Fiscal Year
2010
Total Cost
$7,180,888
Indirect Cost
Name
University of Miami School of Medicine
Department
Neurology
Type
Schools of Medicine
DUNS #
052780918
City
Coral Gables
State
FL
Country
United States
Zip Code
33146
Martin, Renee' H; Yeatts, Sharon D; Hill, Michael D et al. (2016) ALIAS (Albumin in Acute Ischemic Stroke) Trials: Analysis of the Combined Data From Parts 1 and 2. Stroke 47:2355-9
Ginsberg, Myron D; Hill, Michael D (2015) Symptomatic intracranial hemorrhage in the ALIAS Multicenter Trial: relationship to endovascular thrombolytic therapy. Int J Stroke 10:494-500
Hill, Michael D; Martin, Renee H; Palesch, Yuko Y et al. (2015) Albumin Administration in Acute Ischemic Stroke: Safety Analysis of the ALIAS Part 2 Multicenter Trial. PLoS One 10:e0131390
Ginsberg, Myron D; Palesch, Yuko Y; Hill, Michael D et al. (2013) High-dose albumin treatment for acute ischaemic stroke (ALIAS) Part 2: a randomised, double-blind, phase 3, placebo-controlled trial. Lancet Neurol 12:1049-58
Hill, Michael D; Martin, Renee H; Palesch, Yuko Y et al. (2011) The Albumin in Acute Stroke Part 1 Trial: an exploratory efficacy analysis. Stroke 42:1621-5
Ginsberg, Myron D (2011) Visualizing the cortical microcirculation in patients with stroke. Crit Care Med 39:1228-30
Ginsberg, Myron D; Palesch, Yuko Y; Martin, Renee H et al. (2011) The albumin in acute stroke (ALIAS) multicenter clinical trial: safety analysis of part 1 and rationale and design of part 2. Stroke 42:119-27
Zhao, Wenle; Waldman, Bonnie D; Dillon, Catherine et al. (2010) A web-based medical safety reporting system for a large multicenter clinical trial: the ALIAS experience. Contemp Clin Trials 31:536-43
Zhao, Wenle; Ciolino, Jody; Palesch, Yuko (2010) Step-forward randomization in multicenter emergency treatment clinical trials. Acad Emerg Med 17:659-65
Mullen, Michael T; Pantelyat, Alexander; Pukenas, Bryan A et al. (2010) Teaching NeuroImages: occlusion of all 4 major extracranial vessels. Neurology 75:e51

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