CAST 1997.
Study characteristics | ||
Methods | Concealment: centrally produced, prepacked, sequentially numbered envelopes Exclusions during trial: 0 Losses to follow‐up: 451 (219 treatment, 232 control) at 4 weeks |
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Participants | China 21,106 participants 63% male 28% aged > 70 years 87% had CT before entry Ischaemic stroke < 48 hours since stroke onset |
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Interventions | Treatment: aspirin 160 mg once daily orally or via nasogastric tube Control: placebo Duration: 4 weeks, or until death or earlier discharge |
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Outcomes |
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Funding source | Medical Research Council supported the Clinical Trial Service Unit, Oxford. Trial tablets donated by Shandong Xinhua Pharmaceuticals. |
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Notes | Exclusions not specified by protocol but by responsible physician, possibly including increased risk of adverse effects, or little likelihood of any worthwhile benefit in hospital. Follow‐up: 4 weeks. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random component in the sequence generation described. |
Allocation concealment (selection bias) | Low risk | Sequentially numbered envelopes used. |
Blinding of participants and personnel (performance bias) all outcomes | Unclear risk | Unclear whether there was blinding of participants and personnel. |
Blinding of outcome assessment (detection bias) all outcomes | Unclear risk | Unclear whether there was blinding of outcome assessment. |
Incomplete outcome data (attrition bias) all outcomes | Low risk | Missing outcome data balanced in numbers across intervention groups. |
Selective reporting (reporting bias) | Low risk | Study protocol available. |
Other bias | Low risk | No other sources of bias identified. |