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Kawasaki DiseaseNCT02359643

Multi-center Prospective Randomized Control Trail of High Dose Aspirin in Acute Stage of Kawasaki Disease

A study testing Aspirin in people with Kawasaki Disease, run by Chang Gung Memorial Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Kawasaki Disease
What is being tested?
Aspirin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
No sites listed yet
Study dates
May 2013to Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 1. 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.

Who cannot join

  • 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

About this study

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.

Read more

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. 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. 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).
Read the detailed description

All subjects are children who fulfilled the criteria for KD and who are treated with IVIG at each hospital after informed contents are obtained. The patients are initially treated with a single dose of IVIG (2 g/kg) during a 12-hour period.

Principal clinical features of KD that occur in the acute stage within 5 days of the onset of fever will be recorded. After the informed content from the parents, PB samples will be obtained before IVIG treatment (pre-IVIG, KD1), within 3 days after complete initial IVIG treatment (post-IVIG, KD2) as the acute stage samples and then 1 month, 6 month and 12 month followed-up as subacute/convalescent stage samples. CAL was defined as the internal diameter being at least 3 mm of the coronary artery (4 mm if the subject was over the age of 5 years) or the internal diameter of a segment at least 1.5 times as large as that of an adjacent segment by echocardiogram.

High dose aspirin will be given (> 30 mg/kg/day) until the fever subsided at group 1 randomly. After fever subside (<38C, for 48 hours) low-dose aspirin (3-5 mg/kg/day) will be prescribed for all patients until all signs of inflammation resolved in both group 1 and 2.

Being tested
Aspirin
Keywords
Kawasaki disease
Medical subject headings
Mucocutaneous Lymph Node Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AspirinDrug

    Also called acetylsalicylic acid

    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).
Study groups in NCT02359643
Study groupRoleWhat they receive
with high dose aspirinPlacebo comparatorKD 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.
Receives: Drug: Aspirin
Without high dose aspirinExperimentalKD 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.
Receives: Drug: Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess total hospital day

    Measured: 5-10 days

Secondary outcomes (3)

  1. To assess total fever duration

    Measured: 5-10 days

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

    IVIG resistance: more than 2 times of IVIG (2gm/kg); or IVIG responsive: only treatment with one time of IVIG (2gm/kg)

    Measured: 21 days

  3. To examine whether coronary artery lesion formation (CAL)

    CAL was defined as the internal diameter being at least 3 mm of the coronary artery (4 mm if the subject was over the age of 5 yr) or the internal diameter of a segment at least 1.5 times as large as that of an adjacent segment by echocardiogram

    Measured: 6-8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2015 (estimated)
  2. Study startMay 2013
  3. Primary completionApr 2017 (estimated)
  4. Study completionApr 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02359643
Sponsor's protocol ID
Kawasaki Disease
Status last verified
May 2013
First submitted
5 Jan 2015
Last updated
2 Feb 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15545617

  • 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.

    PubMed 22727889

Questions about this trial

What is this clinical trial studying?

A study testing Aspirin in people with Kawasaki Disease, run by Chang Gung Memorial Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess total hospital day (time frame: 5-10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02359643, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016; AzTrials last refreshed its copy on 6 Nov 2026.

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