CHANCE.
| Study characteristics | ||
| Methods | Randomised, double‐blind, placebo‐controlled trial | |
| Participants | 5170 participants (3350 men, 1750 women) of Chinese ethnicity took part in the study. Participants had a history of stroke or TIA. Age of participants was greater than 40 years. Participants with acute non‐disabling ischaemic stroke (NIHSS ≤ 3 at the time of randomisation) that can be treated with study drug within 24 hours of symptoms onset; or TIA (neurological deficit attributed to focal brain ischaemia, with resolution of the deficit within 24 hours of symptom onset), that can be treated with study drug within 24 hours of symptoms onset and with moderate‐to‐high risk of stroke recurrence (ABCD2 score ≥ 4 at the time of randomisation) | |
| Interventions | Clopidogrel 75 mg once daily (loading dose 300 mg first day) and aspirin 75 mg vs placebo and aspirin 75 mg. On the first day all participants received open‐label aspirin at a clinician‐determined dose of 75 to 300 mg per day. 165 participants in the combination group and 146 participants in the aspirin‐only group had stopped taking their medicine at the time of follow‐up. |
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| Outcomes | Primary outcome: any stroke (ischaemic or haemorrhage) at 90 days follow‐up Secondary outcome: participants with the 3‐month new clinical vascular events (ischaemic stroke/haemorrhagic stroke/TIA/MI/vascular death) as a cluster and evaluated individually. Modified Rankin Scale score changes (continuous) and dichotomised at percentage with score 0 to 2 vs 3 to 6 at 3‐month follow‐up. Further efficacy exploratory analysis: impairment (changes in NIHSS scores at 3‐month follow‐up) and quality of life (EuroQol EQ‐5D scale) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Centralised, automated system random assignment |
| Allocation concealment (selection bias) | Low risk | Site randomisation different from primary team |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐dummy, double‐blind |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 20 of 2584 participants (0.8%) in the combination group (clopidogrel + aspirin) and 16 of 2586 participants (0.6%) in the aspirin‐alone group were lost to follow‐up. |
| Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes reported |