The staff of the Neurosciences Trials Unit coordinated the study, and randomization was provided by staff at the Clinical Trial Service Unit in Oxford. National Center for Biotechnology Information , U. Journal List Trials v. Published online Apr Author information Article notes Copyright and License information Disclaimer. Corresponding author. Peter AG Sandercock: ku. Received Sep 22; Accepted Apr This article has been corrected. See Trials. This article has been cited by other articles in PMC.
CSV 4. Abstract Background We aimed to make individual patient data from the International Stroke Trial IST , one of the largest randomised trials ever conducted in acute stroke, available for public use, to facilitate the planning of future trials and to permit additional secondary analyses.
Methods For each randomised patient, we have extracted data on the variables assessed at randomisation, at the early outcome point days after randomisation or prior discharge and at 6-months and provide them as an analysable database.
Conclusions The IST dataset provides a source of primary data which could be used for planning further trials, for sample size calculations and for novel secondary analyses. Results Consent for publication of raw data was not obtained from participants. Table 1 Country codes used in International Stroke Trial. Open in a separate window. Table 2 Variables names and comments.
The terminology for the allocated dose of unfractioned heparin changed slightly from the pilot to the main study. Patients were allocated either units subcutaneously twice daily coded as H in the pilot and M in the main trial , units twice daily coded as L throughout or to 'avoid heparin' coded as N throughout.
Should not have been randomised 2. Refused treatment 3. Initial event not a stroke 4. Haemorrhagic stroke 5. Non compliers 6. Discharged after 14 days 7. Discharged up to 14 days 8. Died prior to receiving the study drug s 9. Died after receiving the study drug s Stated atrial fibrillation Administration problem Missed out more than 3 doses Haemorrhagic stroke.
Table 4 Final diagnosis of initial event. Number Ischaemic stroke Haemorrhagic stroke Definite stroke, pathological type unknown Not a stroke Uncertain diagnosis 26 Total Anonymisation As recommended by Hrynaszkiewicz et al.
Discussion This large data set, with very complete follow-up, includes a very broad range of acute stroke patients with a uniquely large number of very elderly patients, and so may be useful to researchers planning future research studies.
Competing interests The trial was designed, conducted, analyzed, and reported independently of all sponsors. Note for users of the data set The authors ask that any publications arising from the use of this dataset acknowledges the source of the dataset, its funding and the collaborative group that collected the data. Authors' contributions PS was the Chief Investigator of the IST responsible for the overall design, conduct and presentation of the study results.
Click here for file 4. Metrics details. An Erratum to this article was published on 06 March We aimed to make individual patient data from the International Stroke Trial IST , one of the largest randomised trials ever conducted in acute stroke, available for public use, to facilitate the planning of future trials and to permit additional secondary analyses.
For each randomised patient, we have extracted data on the variables assessed at randomisation, at the early outcome point days after randomisation or prior discharge and at 6-months and provide them as an analysable database. Over Background stroke care was limited and none of the patients received thrombolytic therapy.
The IST dataset provides a source of primary data which could be used for planning further trials, for sample size calculations and for novel secondary analyses. Given the age distribution and nature of the background treatment given, the data may be of value in planning trials in older patients and in resource-poor settings.
Peer Review reports. The International Stroke Trial IST was conducted between and including the pilot phase between and The aim of the trial was to establish whether early administration of aspirin, heparin, both or neither influenced the clinical course of acute ischaemic stroke [ 1 ].
The inclusion criteria were: clinical diagnosis of acute ischaemic stroke, with onset within the previous 48 hours and no clear indication for, or clear contraindication to, treatment with aspirin or subcutaneous heparin. Unlike many stroke trials of that era and subsequently , the study did not set an upper age limit.
Patients were to have a CT brain scan to confirm the diagnosis of stroke, and this was to be done before randomisation if at all possible. To enter a patient in the study, the clinician telephoned a central randomisation service at the Clinical Trial Service Unit, Oxford during this telephone call, the baseline variables were entered and checked, and once validated, the computer allocated the treatment and the telephonist then informed the clinician.
The patients and treating clinicians were not blinded to the treatment given. Early outcome data were collected by the treating physician who completed a follow-up form at 14 days, death or hospital discharge whichever occurred first. This form recorded data on events in hospital within 14 days, and the doctor's opinion on the final diagnosis of the initial event that led to randomisation.
These unblinded data, may therefore be subject to some degree of bias. The primary outcome was the proportion of patients who were either dead or dependent on other people for activities of daily living at six months after randomisation. This outcome was collected by postal questionnaire mailed directly to the patient, or in Italy by telephone interview of the patient by a trained researcher, blinded to treatment allocation.
The primary outcome was therefore assessed - as far as practicable - blind to treatment allocation and hence should be free from bias. We re-checked the data set for inaccuracies and inconsistencies and extracted data on the variables assessed at randomisation, and at the two outcome assessment points: at days after randomisation, death or prior hospital discharge whichever occurred first and at 6-months. Consent for publication of raw data was not obtained from participants.
Consent for participation in the trial was obtained from all subjects or from an appropriate proxy, according to the procedures approved by relevant national and local hospital ethics committees or Institutional Review Boards [IRB].
These patients were treated years ago, and many have died. Patients and hospitals are identified only by an anonymous code; there are no identifying data such as name, address or social security numbers; patient age has been rounded to the nearest whole number. In our view, publication of the dataset clearly presents no material risk to confidentiality of study participants. The dataset includes the following baseline data: age, gender, time from onset to randomisation, presence or absence of atrial fibrillation AF , aspirin administration within 3 days prior to randomisation, systolic blood pressure at randomisation, level of consciousness and neurological deficit.
We extracted events within 14 days on: the occurrence of recurrent stroke, pulmonary embolism, and death date and cause of death. At 6 months we extracted: degree of recovery, place of residence and current use of antiplatelet or anticoagulant drugs and death date and cause of death.
The cause of death was classified as: due to initial stroke, recurrent ischaemic stroke, recurrent haemorrhagic stroke, pneumonia, coronary artery disease, pulmonary embolism, other vascular cause or a nonvascular cause. Patients were assigned to one of 6 categories according to the place of residence at 6 months following stroke: own home, relatives home, residential care, nursing home, other hospital departments or unknown.
The variables extracted are listed with a brief description of each in Tables 1 , 2 and 3. Nineteen thousand four hundred and thirty five patients from hospitals in 36 countries were randomised within 48 hours of symptoms onset, of whom had a CT before randomisation, were first scanned after randomisation and were not scanned at all.
Five thousand one hundred thirty two Given that patients were first scanned after randomisation, and were not scanned at all, the 'final diagnosis' is somewhat imprecise. However, since the analysis was by intention to treat, all participants were retained in the analysis, irrespective of the final diagnosis. Half the patients were allocated unfractionated heparin or 12, IU bd [twice daily] , and half were allocated "avoid heparin"; and, in a factorial design, half were allocated aspirin mg daily and half "avoid aspirin".
The primary outcomes were death within 14 days and death or dependency at 6 months. Results: Among heparin-allocated patients, there were non-significantly fewer deaths within 14 days [9.
At 6 months the percentage dead or dependent was identical in both groups Patients allocated to heparin had significantly fewer recurrent ischaemic strokes within 14 days 2.
Heparin was associated with a significant excess of 9 SD 1 transfused or fatal extracranial bleeds per Compared with IU bd heparin, 12, IU bd heparin was associated with significantly more transfused or fatal extracranial bleeds, more haemorrhagic strokes, and more deaths or non-fatal strokes within 14 days
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