KD-CAAP

Kawasaki Disease Coronary Artery Aneurysm Prevention trial

“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 (CAA) in Kawasaki disease (KD)”

KD-CAAP is aiming to determine whether adding immediate corticosteroid treatment to standard of care IVIG and aspirin will reduce coronary artery aneurysm (CAA) rates in unselected Kawasaki Disease (KD) patients across Europe compared with IVIG and aspirin alone.

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.

http://kdcaap.mrcctu.ucl.ac.uk/

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), Radboudumc, UMC Utrecht, MMC Veldhoven, UMC Groningen.