Different dose aspirin plus immunoglobulin (DAPI) for prevention of coronary artery abnormalities in Kawasaki disease: Study protocol for a multi-center, prospective, randomized, open-label, blinded end-point, non-inferiority trial
Study context
- Population
- Children and adolescents under 18 with Kawasaki disease, recruited from inpatient unitsplanned sample size
- Participants
- 1,346 children
- Planned comparison
- Low-dose vs moderate-dose aspirin, each with IV immunoglobulin, as initial treatment
Methodological detailsmulticentre, prospective, open-label, blinded end-point, non-inferiority, 1:1 randomisation, China, planned 2023–2026, ITT analysis planned, 80% power, one-sided significance level 0.025
- Multicentre
- Prospective
- Open-label
- Blinded end-point
- Non-inferiority
- 1:1 randomisation
- China
- Planned 2023–2026
- ITT analysis planned
- 80% power, one-sided significance level 0.025
No results yet. This paper sets out the design of a trial; its results are to come.
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Different dose aspirin plus immunoglobulin (DAPI) for prevention of coronary artery abnormalities in Kawasaki disease: Study protocol for a multi-center, prospective, randomized, open-label, blinded end-point, non-inferiority trial. Am Heart J. Published 19 March 2024. doi:10.
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