PRoFESS.
Study characteristics | ||
Methods | Randomised. Allocation concealment | |
Participants | 1360 participants (884 men and 476 women) with a history of stroke. Age of participants was greater than 55 years. Participants had to be hospitalised with stable stroke. 5 of 672 participants in the combination group (aspirin + extended‐release dipyridamole) and 7 of 688 participants in the clopidogrel‐only group were lost to follow‐up. 36 participants complained of headache in the combination group, whilst 3 participants in the clopidogrel‐only group reported adverse effects. | |
Interventions | Aspirin 25 mg twice daily plus extended‐release dipyridamole 200 mg twice daily vs clopidogrel 75 mg alone once daily followed for 90 days | |
Outcomes | Primary outcome: mRS at 30 days Secondary outcome: recurrent stroke, haemorrhagic transformation |
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Notes | Subset of participants enrolled early | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Methods described. |
Allocation concealment (selection bias) | Low risk | Methods described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 12 of 1360 participants (0.8%) lost to follow‐up |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes reported |