Rödén‐Jüllig 2003.
Study characteristics | ||
Methods | Randomisation: randomisation tables, stratified for gender Concealment: sequentially numbered containers from pharmacy Double blind Exclusions during trials: none Losses to follow‐up: none |
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Participants | Sweden 441 participants 226 (51%) male 100% CT before entry Ischaemic stroke < 72 hours since stroke onset SSSS ≥ 1 point |
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Interventions | Treatment: aspirin 325 mg orally once daily Control: placebo Duration: 5 days |
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Outcomes |
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Funding source | The trial was supported by grants from the Serafimer Hospital Foundation, the County Council of Stockholm, Department of Research, Development & Education, the Claes Groschinsky Foundation, the Loo and Hans Osterman Foundation, the Eirs 50‐year Foundation, the SALUS 50‐year Foundation, the 1987 Foundation for Stroke Research, the Tore Nilsson Foundation for Medical Research and the Karolinska Institutet Foundations for Research. Miles Inc through Bayer AG provided the placebo tablets free of charge. The aspirin tablets were purchased from Miles Inc. These companies were not involved in the conduct of this trial in any other way. |
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Notes | Exclusions: specified in protocol – severe concomitant medical conditions or pre‐existing neurological illness, bleeding risk, blood pressure > 240/140 mmHg Follow‐up: 3 months |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Standard randomisation tables used. |
Allocation concealment (selection bias) | Low risk | Packages taken in numerical order. |
Blinding of participants and personnel (performance bias) all outcomes | Low risk | Participants and personnel blinded. |
Blinding of outcome assessment (detection bias) all outcomes | Low risk | No concerns regarding blinding of outcome assessment. |
Incomplete outcome data (attrition bias) all outcomes | Low risk | No missing outcome data. |
Selective reporting (reporting bias) | Low risk | Study protocol noted. |
Other bias | Low risk | No sources of other bias identified. |