The first international stroke trial (IST) suggested thataspirin should be administered to stroke patients as soon as possible after the
onset of ischaemic stroke. Published in 1997, its recommendations are now part
of mainstream clinical practice. The results of the latest IST trial; IST-3, are published in The
Lancet this week – with a number of supporting preliminary publications in
BioMed Central journals and databases –and promise to be just as influential on
the treatment of ischaemic stroke.
Comprising data from patients recruited across 12 countries, the IST-3 trial
ran from 2000 to 2011 making it the largest acute stroke thrombolysis study
population ever. The trial found that patients treated with the thrombolytic
drug rt-PA (recombinant
tissue plasminogen activator) within six hours were less likely to be left with permanent
disabilities and were more likely to make a full recovery within six months of
their stroke. As the largest acute stroke thrombolysis trial yet, the
study was also able to assess the impact of rt-PA on critical patient subgroups
such as stroke victims over the age of 80 years, a group traditionally seen as at
risk when treated with rt-PA. In 2002 the drug was granted an EU licence on the
condition that it was only given to patients under 80, within three hours of a
stroke. With this in mind the IST-3 trialists sought to establish whether
treatment with rt-PA was suitable for patients over 80, up to six hours after a
stroke.
The results of the trial suggest that extending treatment with rt-PA to
patients over 80 can be recommended, as Chief investigator Professor Peter Sandercock
of the University of Edinburgh’s Centre for Clinical Brain Sciences and
Associate Editor of Trials said: “Our
trial shows that it is crucial that treatment is given as fast as possible to
all suitable patients.” Co- investigator, Richard Lindley, Professor of
Geriatric Medicine from the University of Sydney’s Medical School, added:
“Please don’t ignore the over 80s – they benefit hugely.”
Since IST-1 published its findings, the potential for publication and sharing
of clinical research data has undergone a marked shift. New technologies
combined with transparency initiatives such as the CONSORT statement enable researchers to
make their trial-related publications and data as widely accessible as
possible. The movement towards transparency in clinical research – helping to
facilitate publication of a complete electronic thread of publications from
study registration through protocols, results and data – has been central to the IST project. The IST-3
co-ordinators registered their trial (ISRCTN25765518) initially in the ISRCTN database and later published the study protocol for the IST-3 project as well a
subsequent update on the project’s progress in BioMed
Central’s journal Trials. Further IST-3-related
publications, such as the statistical analysis plan, have appeared in other
journals, and these are listed on the IST-3
study website. Following publication of the IST-3 findings in The
Lancet, the authors will make all of the previous articles in the IST
series freely available on their website.
This commitment to transparency is one reason that BioMed Central and
LabArchives were proud to present Peter Sandercock and the IST group with the
Open Data Award for their article “The
International Stroke Trial database”. Presented at the BioMed Central
Annual Research Awards, the award recognizes researchers who have published in
BioMed Central journals and have demonstrated leadership in the sharing,
standardization, publication, or re-use of biomedical research data. Published
in Trials, “The
International Stroke Trial database” article and data set makes the raw
data from the first IST trial published in 1997 publically available for the
first time.
The IST-3 study’s comprehensive trial design and the authors’ leadership in the
area of accessible and re-usable data suggest that the results of the article
will be a material benefit to the clinical community. BioMed Central congratulates
the IST team and is looking forward to working with their publications as we
further develop the concept of Threaded
Publications.
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