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.
Stroke is the third leading cause of death and the major cause of chronic disability. In spite of large experimental literature that shows the effectiveness of acute intervention to achieve substantial neuroprotection of ischemically threatened brain, to date, no clinically proven agents exist. Therefore, the aim of the ALIAS Part 2 Trial in identifying ALB as a potential neuroprotective agent is still relevant, and a positive result from the Trial would have a significant impact on the clinical practice of AIS treatment.
|Ciolino, Jody D; Martin, Renee' H; Zhao, Wenle et al. (2014) Continuous covariate imbalance and conditional power for clinical trial interim analyses. Contemp Clin Trials 38:9-18|