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: email@example.com; firstname.lastname@example.org
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:
- any CAA documented within 3 months;
- 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, CWZ Nijmegen, MMC Veldhoven, UMC Groningen (reservelijst: ErasmusMC).