NCT02359643

Brief Summary

Kawasaki disease (KD) is an acute multi-system vasculitis syndrome of unknown etiology occurring mostly in infants and children younger than 5 years of age. In developed countries, it is the leading cause of acquired heart disease in children. However, KD remains a mysterious disease. Single high dose intravenous immunoglobulin (IVIG, 2gm/kg) and aspirin are standard treatment for KD. Aspirin have been prescribed in treatment of KD for decade even earlier than usage of IVIG. High dose aspirin mainly act as anti-inflammation, while low dose aspirin as anti-platelet. IVIG may play most of the role of anti-inflammation in acute stage of KD. Hsieh et al. reported that KD without high dose aspirin had the same treatment response after IVIG. Therefore it is still unclear about the necessarily of high dose aspirin in acute stage of KD. This study was conduct to investigate the role of high dose aspirin in acute stage of KD via a multi-center randomized control trail, and we plan to achieve the followings till year 2017:

  1. 1.Enroll 300 KD patients from multiple medical centers . Randomize group patients as group 1: with high dose aspirin (more than 30/mg/kd/day) until fever subsided and shift to low dose aspirin (3-5mg/kg/day, N=150); and group 2: without high dose aspirin during acute febrile stage, only use low dose aspirin (N=150).
  2. 2.Compare data including fever days, admission duration, laboratory data (CBC/DC, GOT/GPT, BUN/Cr, Alb, ESR, CRP, 2D echo), IVIG treatment response and CAL formation rate (followed at least 1 year).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

February 2, 2016

Status Verified

May 1, 2013

Enrollment Period

3.9 years

First QC Date

January 5, 2015

Last Update Submit

January 31, 2016

Conditions

Kawasaki Disease

Keywords

Kawasaki disease

Outcome Measures

Primary Outcomes (1)

  • To assess total hospital day

    5-10 days

Secondary Outcomes (3)

  • To assess total fever duration

    5-10 days

  • To assess how many times of intramenous immunoglobulin (IVIG) treatment

    21 days

  • To examine whether coronary artery lesion formation (CAL)

    6-8 weeks

Study Arms (2)

with high dose aspirin

PLACEBO COMPARATOR

KD patients treated with high dose IVIG (2gm/kg) and high dose aspirin (\>50mg/kg/day) since diagnosed, then taper to low dose aspirin (3-5mg/kg/day) when fever subside.

Drug: Aspirin

Without high dose aspirin

EXPERIMENTAL

KD patients treated with high dose IVIG (2gm/kg) without high dose aspirin (\>50mg/kg/day) since diagnosed, then low dose aspirin (3-5mg/kg/day) when fever subside.

Drug: Aspirin

Interventions

AspirinDRUG

This study was conduct to investigate the role of high dose aspirin in acute stage of KD via a multi-center randomized control trail, and we plan to achieve the followings in the coming 4 years: 1. Enroll 300 KD patients from multiple medical centers of Taiwan and China in 4 years. Randomize group patients as group 1: with high dose aspirin (more than 30/mg/kd/day) until fever subsided and shift to low dose aspirin (3-5mg/kg/day, N=150); and group 2: without high dose aspirin during acute febrile stage, only use low dose aspirin (N=150). 2. Compare data including fever days, admission duration, laboratory data (CBC/DC, GOT/GPT, BUN/Cr, Alb, ESR, CRP, 2D echo), IVIG treatment response and CAL formation rate (followed at least 1 year).

Also known as: acetylsalicylic acid
Without high dose aspirinwith high dose aspirin

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. All subjects are children who fulfilled the criteria for Kawasaki Disease (American Heart Association criteria).
  • Fever \> 5 days, and 4 of the 5 following symptoms
  • Diffuse mucosal inflammation (strawberry tongue, dry and fissured lips)
  • Bilateral non-purulent conjunctivitis,
  • Dysmorphous skin rashes,
  • Indurative angioedema over the hands and feet
  • Cervical lymphadenopathy. (One or more nodule at lease 1.5 cm in diameter) 2. KD patients are treated with IVIG at each hospital after informed contents are obtained.

You may not qualify if:

  • Patients whose symptoms did not full fit the Kawasaki Disease criteria.
  • Had an acute fever for \< 5 days and \>10 days
  • Incomplete collection of each followed-up data (CBC/DC, GOT/GPT, BUN/Cr, Albumin, ESR, C-Reactive Protein, 2D echocardiography)
  • IVIG treatment at other hospital before refers to study centers.
  • Treatment with corticosteroids, other than inhaled forms, in the previous 2 weeks before enrollment;
  • The presence of a disease known to mimic Kawasaki disease.
  • Previous diagnosis of Kawasaki disease
  • Inability to take aspirin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Hsieh KS, Weng KP, Lin CC, Huang TC, Lee CL, Huang SM. Treatment of acute Kawasaki disease: aspirin's role in the febrile stage revisited. Pediatrics. 2004 Dec;114(6):e689-93. doi: 10.1542/peds.2004-1037. Epub 2004 Nov 15.

    PMID: 15545617BACKGROUND

  • Chen CH, Lin LY, Yang KD, Hsieh KS, Kuo HC. Kawasaki disease with G6PD deficiency--report of one case and literature review. J Microbiol Immunol Infect. 2014 Jun;47(3):261-3. doi: 10.1016/j.jmii.2012.05.002. Epub 2012 Jun 23.

    PMID: 22727889BACKGROUND

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Interventions

Aspirin

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesCardiovascular DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Ho-Chang Kuo, MD, PhD

    Chang Gung Memorial Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2015

First Posted

February 10, 2015

Study Start

May 1, 2013

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

February 2, 2016

Record last verified: 2013-05