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Evaluation of a sequential global test of improved recovery following stroke as applied to the ICTUS trial of citicoline
Author(s) -
Bolland Kim,
Whitehead John,
Cobo Erik,
Secades Julio J.
Publication year - 2008
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.344
Subject(s) - citicoline , medicine , stroke (engine) , modified rankin scale , randomized controlled trial , placebo , interim analysis , physical therapy , clinical trial , ischaemic stroke , tissue plasminogen activator , ischemic stroke , anesthesia , alternative medicine , ischemia , mechanical engineering , engineering , pathology
The International Citicoline Trial in acUte Stroke is a sequential phase III study of the use of the drug citicoline in the treatment of acute ischaemic stroke, which was initiated in 2006 in 56 treatment centres. The primary objective of the trial is to demonstrate improved recovery of patients randomized to citicoline relative to those randomized to placebo after 12 weeks of follow‐up. The primary analysis will take the form of a global test combining the dichotomized results of assessments on three well‐established scales: the Barthel Index, the modified Rankin scale and the National Institutes of Health Stroke Scale. This approach was previously used in the analysis of the influential National Institute of Neurological Disorders and Stroke trial of recombinant tissue plasminogen activator in stroke. The purpose of this paper is to describe how this trial was designed, and in particular how the simultaneous objectives of taking into account three assessment scales, performing a series of interim analyses and conducting treatment allocation and adjusting the analyses to account for prognostic factors, including more than 50 treatment centres, were addressed. Copyright © 2008 John Wiley & Sons, Ltd.