Published Online
on April 19, 2007

A more recent version of this article appeared on June 1, 2007

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Submitted on October 15, 2006
Revised on December 21, 2006
Accepted on January 11, 2007

The Virtual International Stroke Trials Archive

Myzoon Ali MRes; Philip M.W. Bath MD, FRCP; John Curram PhD; Stephen M. Davis MD, FRCP, FRACP; Hans-Christoph Diener MD; Geoffrey A. Donnan MD; Marc Fisher MD; Barbara A. Gregson BSc, PhD; James Grotta MD; Werner Hacke MD, PhD; Michael G. Hennerici MD; Marc Hommel MD; Markku Kaste PhD, MD; John R. Marler MD; Ralph L. Sacco MD, MS; Philip Teal MD; Nils-Gunnar Wahlgren MD, PhD; Steven Warach MD, PhD; Christopher J. Weir PhD; and Kennedy R. Lees MD, FRCP^*

From the University Department of Medicine and Therapeutics (M.A.), Gardiner Institute, Western Infirmary, Glasgow, UK; Institute of Neuroscience (P.M.W.B.), University of Nottingham, Nottingham, UK; Bayer Plc (J.C.), Newbury, Berkshire, UK; Department of Neurology (S.M.D.), Royal Melbourne Hospital, University of Melbourne, Melbourne, Australia; Department of Neurology (H.C.D.), University Duisburg-Essen, Essen, Germany; Department of Neurology (G.A.D.), University of Melbourne, Melbourne, Australia; Department of Neurology (M.F.), University of Massachusetts Medical School, Worcester, Mass; Department of Neurosurgery (B.A.G.), Newcastle University, Newcastle General Hospital, Newcastle, UK; Department of Neurology (J.G.), University of Texas at Houston Medical School, Houston, Tex; Department of Neurology (W.H.), University of Heidelberg, Heidelberg, Germany; Department of Neurology (M.G.H.), Universitätsklinikum Mannheim, University of Heidelberg, Heidelberg, Germany; Joseph Fourier University (M.H.), Grenoble, France; Department of Neurology (M.K.), Helsinki University Central Hospital, University of Helsinki, Helsinki, Finland; National Institute of Neurological Disorders and Stroke (J.R.M.), Bethesda, Md; Departments of Neurology and Epidemiology (R.L.S.), Columbia University, New York, NY; University of British Columbia (P.T.), Vancouver, Canada; Karolinska Hospital (N.G.W.), Stockholm, Sweden; National Institute of Neurological Disorders and Stroke (S.W.), Bethesda, Md; Robertson Centre for Biostatistics (C.J.W.), Glasgow, UK; and the Gardiner Institute (K.R.L.), Western Infirmary, Glasgow, UK.

^* To whom correspondence should be addressed. E-mail: k.r.lees{at}clinmed.gla.ac.uk.

Background and Purpose--Stroke has global importance and it causes an increasing amount of human suffering and economic burden, but its management is far from optimal. The unsuccessful outcome of several research programs highlights the need for reliable data on which to plan future clinical trials. The Virtual International Stroke Trials Archive aims to aid the planning of clinical trials by collating and providing access to a rich resource of patient data to perform exploratory analyses.

Methods--Data were contributed by the principal investigators of numerous trials from the past 16 years. These data have been centrally collated and are available for anonymized analysis and hypothesis testing.

Results--Currently, the Virtual International Stroke Trials Archive contains 21 trials. There are data on >15 000 patients with both ischemic and hemorrhagic stroke. Ages range between 18 and 103 years, with a mean age of 69±12 years. Outcome measures include the Barthel Index, Scandinavian Stroke Scale, National Institutes of Health Stroke Scale, Orgogozo Scale, and modified Rankin Scale. Medical history and onset-to-treatment time are readily available, and computed tomography lesion data are available for selected trials.

Conclusions--This resource has the potential to influence clinical trial design and implementation through data analyses that inform planning.

Key words: clinical trials • trial design • natural history • database • modified Rankin Scale • National Institutes of Health Stroke Scale

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