Title: Multi-centre, randomised, open-label, blinded endpoint assessed, trial of corticosteroids plus intravenous immunoglobulin (IVIG) and aspirin, versus IVIG and aspirin for prevention of coronary artery aneurysms in Kawasaki disease.

Sponsor: University College London (UCL)

Details of the trial contact:

Name: Dr Despina Eleftheriou and Prof Paul Brogan (Joint Chief Investigators)

Contact Email: d.eleftheriou@ucl.ac.uk; p.brogan@ucl.ac.uk

Contact Phone Number: 0044-02079052182

Experimental Design: multicentre randomised, controlled, open-label, blinded endpoint assessed trial.

Hypothesis: Adding corticosteroid treatment to IVIG and aspirin will reduce CAA rates in unselected KD patients across Europe compared with IVIG and aspirin alone.

Objective: To determine the efficacy and safety of adjunctive corticosteroid therapy combined with IVIG/aspirin for prevention of CAA in unselected patients with KD across Europe. Planned enrollment is 262 children over 30 months from 30 centres across Europe. An overview of KD-CAAP is summarised in the Figure.

Primary endpoint: KD-CAAP will have two co-primary outcome measures:

  1. any CAA documented within 3 months;
  2. maximum coronary Z-score at weeks 1, 2, 6 adjusting for rescue treatment.

Participating centers in the Netherlands: AmsterdamUMC (AMC), Haga Ziekenhuis, Radboudumc, UMC Utrecht, MMC Veldhoven, UMC Groningen (reservelijst: ErasmusMC).