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Multi-centre, rando...
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) : the KD CAA prevention (KD-CAAP) trial protocol
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- Eleftheriou, Despina (author)
- UCL Institute of Child Health
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- Moraes, Yolanda Collaco (author)
- British Medical Research Council (MRC)
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- Purvis, Cara (author)
- British Medical Research Council (MRC)
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- Pursell, Molly (author)
- British Medical Research Council (MRC)
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- Morillas, Marta Merida (author)
- British Medical Research Council (MRC)
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- Kahn, Robin (author)
- Lund University,Lunds universitet,Pediatrik, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Lund Pediatric Rheumatology Research Group,Forskargrupper vid Lunds universitet,Barnreumatologiskt forskningscentrum,WCMM- Wallenberg center för molekylär medicinsk forskning,Paediatrics (Lund),Section V,Department of Clinical Sciences, Lund,Faculty of Medicine,Lund University Research Groups,Center of Pediatric Rheumatology,WCMM-Wallenberg Centre for Molecular Medicine
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- Mossberg, Maria (author)
- Lund University,Lunds universitet,Barninfektioner och global barn- och ungdomshälsa,Forskargrupper vid Lunds universitet,Pediatrik infectious diseases and global child health,Lund University Research Groups
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- Kucera, Filip (author)
- Great Ormond Street Hospital
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Tulloh, Robert (author)
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- Standing, Joseph F. (author)
- UCL Institute of Child Health
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- Swallow, Veronica (author)
- Sheffield Hallam University
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McCormack, Rachael (author)
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- Herberg, Jethro (author)
- Imperial College London
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- Levin, Michael (author)
- Imperial College London
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- Wan, Mandy (author)
- King's College London,Evelina London Children's Healthcare
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- Klein, Nigel (author)
- UCL Institute of Child Health
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- Connon, Roisin (author)
- British Medical Research Council (MRC)
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- Walker, Ann Sarah (author)
- British Medical Research Council (MRC)
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- Brogan, Paul (author)
- UCL Institute of Child Health
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(creator_code:org_t)
- 2023-01-26
- 2023
- English.
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In: Trials. - : Springer Science and Business Media LLC. - 1745-6215. ; 24:1
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Abstract
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- Background: Kawasaki disease (KD) is an acute self-limiting inflammatory vasculitis affecting predominantly medium-sized arteries, particularly the coronary arteries. A number of recent studies conducted in different European countries have demonstrated alarmingly high coronary complications despite treatment with intravenous immunoglobulin (IVIG). These high complication rates now emphasize the need for an urgent reappraisal of IVIG as the sole primary therapeutic agent for KD. The Kawasaki disease CAA prevention (KD-CAAP) trial will test the hypothesis that immediate adjunctive corticosteroid treatment to standard of care IVIG and aspirin will reduce coronary artery aneurysm (CAA) rates in unselected KD patients across Europe. Methods: KD-CAAP is a multicentre, randomised, controlled, open-label, blinded endpoint assessed trial that will be conducted across Europe supported by the conect4children pan-European clinical trials network. Patients with KD who satisfy the eligibility criteria will be randomised (1:1) to receive either oral prednisolone 2 mg/kg/day plus standard of care therapy IVIG (2 g/kg) and aspirin (40 mg/kg/day); or IVIG and aspirin alone. Further management is dictated by temperature and C-reactive protein (CRP) responses. Co-primary outcomes are as follows: (i) any CAA within the 3 months of trial follow-up; (ii) average estimate of maximum coronary Z-score at weeks 1, 2 and 6 adjusting for rescue treatment. Additional outcomes will be assessed including cost effectiveness, quality of life, corticosteroid toxicity and other safety outcomes. Discussion: Several recent studies have indicated that coronary complications associated with KD across Europe are much higher than early trials of IVIG had initially suggested. KD-CAAP directly addresses this issue by exploring the therapeutic benefit of adjunctive corticosteroids in unselected KD cases. If we find that corticosteroids prevent CAA and are safe, this is a cheap and widely available intervention that could be implemented immediately for the benefit of children. Trial registration: ISRCTN71987471- March 31, 2020; Eudract 2019–004433-17.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Keyword
- Coronary artery aneurysms
- Corticosteroids
- Kawasaki disease
Publication and Content Type
- art (subject category)
- ref (subject category)
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Eleftheriou, Des ...
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Moraes, Yolanda ...
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Purvis, Cara
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Pursell, Molly
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Morillas, Marta ...
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Kahn, Robin
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Mossberg, Maria
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Kucera, Filip
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Tulloh, Robert
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Standing, Joseph ...
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Swallow, Veronic ...
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McCormack, Racha ...
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Herberg, Jethro
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Levin, Michael
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Wan, Mandy
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Klein, Nigel
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Connon, Roisin
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Walker, Ann Sara ...
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Brogan, Paul
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Trials
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