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The ALIAS (ALbumin In Acute Stroke) Phase III randomized multicentre clinical trial: design and prog |
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The ALIAS (ALbumin In Acute Stroke) Phase III randomized multicentre clinical trial: design and progress report.
Biochem Soc Trans. 2006 Dec;34(Pt 6):1323-6.
Ginsberg MD, Palesch YY, Hill MD.
Department of Neurology, University of Miami Miller School of Medicine, P.O. Box 016960, Miami, FL 33101, U.S.A.
High-dose
human ALB (albumin) therapy is highly neuroprotective in animal models
of ischaemic stroke. A recently completed 82-subject pilot-phase
dose-escalation trial has shown that ALB is safe, with strong
preliminary suggestions of possible efficacy.
We are now proceeding to
a large randomized, double-blinded, placebo-controlled multicentre
trial funded by the NIH (National Institutes of Health), the ALIAS
(Albumin In Acute Stroke) Phase III Trial, which is designed to
ascertain definitively whether high-dose ALB therapy confers
neuroprotection in subjects with acute ischaemic stroke treated within
5 h of stroke onset. The primary efficacy outcome measure is a
favourable outcome, defined as an NIHSS (NIH Stroke Scale) score of 0-1
or a modified Rankin Scale score of 0-1 at 3 months post-randomization.
Separate randomization (1:1) to ALB or placebo therapy will be carried
out in two cohorts of 900 subjects each, one that receives
standard-of-care thrombolytic therapy and the other that does not.
Approx. 60 North American clinical sites will participate. Subject
enrolment is expected to commence in July 2006.
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