The Virtual International Stroke Trials Archive.
OBJECTIVE
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.
Ali
Myzoon
M
University Department of Medicine and Therapeutics, Gardiner Institute, Western Infirmary, Glasgow, UK.
Bath
Philip M W
PM
Curram
John
J
Davis
Stephen M
SM
Diener
Hans-Christoph
HC
Donnan
Geoffrey A
GA
Fisher
Marc
M
Gregson
Barbara A
BA
Grotta
James
J
Hacke
Werner
W
Hennerici
Michael G
MG
Hommel
Marc
M
Kaste
Markku
M
Marler
John R
JR
Sacco
Ralph L
RL
Teal
Philip
P
Wahlgren
Nils-Gunnar
NG
Warach
Steven
S
Weir
Christopher J
CJ
Lees
Kennedy R
KR
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001109:Archives; D005260:Female; D006801:Humans; D038622:Internationality; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D020521:Stroke / Q000453:epidemiology* / Q000628:therapy