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

January 31, 2016 updated by: Chang Gung Memorial Hospital

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. 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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria: (both 1 and 2)

1. All subjects are children who fulfilled the criteria for Kawasaki Disease (American Heart Association criteria).

  1. Fever > 5 days, and 4 of the 5 following symptoms
  2. Diffuse mucosal inflammation (strawberry tongue, dry and fissured lips)
  3. Bilateral non-purulent conjunctivitis,
  4. Dysmorphous skin rashes,
  5. Indurative angioedema over the hands and feet
  6. 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: with high dose aspirin
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

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).
Other Names:
  • acetylsalicylic acid
Experimental: Without high dose aspirin
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

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).
Other Names:
  • acetylsalicylic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess total hospital day
Time Frame: 5-10 days
5-10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess total fever duration
Time Frame: 5-10 days
5-10 days
To assess how many times of intramenous immunoglobulin (IVIG) treatment
Time Frame: 21 days
IVIG resistance: more than 2 times of IVIG (2gm/kg); or IVIG responsive: only treatment with one time of IVIG (2gm/kg)
21 days
To examine whether coronary artery lesion formation (CAL)
Time Frame: 6-8 weeks
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
6-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Chair: Ho-Chang Kuo, MD, PhD, Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

February 5, 2015

First Posted (Estimate)

February 10, 2015

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

January 31, 2016

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kawasaki Disease

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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