PICASSO sub‐group 2020.
Study characteristics | ||
Methods |
Design: randomised controlled, 2 × 2 factorial parallel group trial Setting: multicentre, 67 hospitals in three Asian countries Dates: 1 August 2009 to 31 August 2015 |
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Participants |
Sample size: 1534 participants overall (288 with prior ICH in the subgroup analysis included in this meta‐analysis) Diagnosis: non‐cardioembolic ischaemic stroke or transient ischaemic attack within 180 days and clinical history of prior ICH Inclusion criteria
Exclusion criteria
Age (years, mean (SD)): unknown for this subgroup with prior ICH Sex: unknown for this subgroup with prior ICH |
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Interventions |
Intervention: cilostazol 100 mg orally twice daily (matching the comparator) Comparator: aspirin 100 mg orally once daily (matching the intervention) |
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Outcomes |
Primary outcomes
Secondary outcomes
Duration of follow‐up: at least 12 months. |
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Notes |
Declarations of interest: SUK declares grants from Korea Otsuka Pharmaceutical Company. All other authors declare no competing interests Sources of funding: Korea Otsuka Pharmaceutical Company |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Interactive web‐based system. each participant received a subject number generated by the computer of the central randomisation service and was randomly assigned (1:1:1:1) to receive cilostazol (with aspirin placebo), aspirin (with cilostazol placebo), cilostazol plus probucol (with aspirin placebo), or aspirin plus probucol (with cilostazol placebo) using centralised blocks (block size 4) stratified by centre |
Allocation concealment (selection bias) | Low risk | The analysis of cilostazol versus aspirin (antiplatelet arm) was double‐blinded, and the interactive web response system was used |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Cilostazol, aspirin, and placebos—used as a double dummy—were provided every 3 months in boxes within sealed opaque envelopes, with instructions to be taken twice a day |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Investigators were blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not mentioned |
Selective reporting (reporting bias) | High risk | Not all were reported |