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A Multi-center, Randomized to Compare the Efficacy of IVIG Alone and IVIG Plus High-dose Aspirin in Kawasaki Disease

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ClinicalTrials.gov Identifier: NCT02951234
Recruitment Status : Recruiting
First Posted : November 1, 2016
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
Kawasaki disease (KD) is an acute febrile systemic vasculitis most commonly seen in children under the age of 5 years old. This trial has been designed as a multi-center, prospective, randomized controlled, evaluator-blinded trial with two parallel groups to determine whether IVIG alone as the primary therapy in acute-stage KD is as effective as IVIG combined with high-dose aspirin therapy. The primary endpoint is defined as CAL formation at 6-8 weeks.

Condition or disease Intervention/treatment Phase
Kawasaki Disease Other: IVIG only Other: IVIG and Aspirin Not Applicable

Detailed Description:

Background: Kawasaki disease (KD) is an acute febrile systemic vasculitis most commonly seen in children under the age of 5 years old. High-dose aspirin is often administered, but the duration of such treatment varies. Many centers reduce the aspirin dose once the patient is afebrile, even before treating said patient with IVIG. However, a randomized controlled trial regarding high-dose aspirin in the acute stage of KD has not previously been carried out.

Methods/design: This trial has been designed as a multi-center, prospective, randomized controlled, evaluator-blinded trial with two parallel groups to determine whether IVIG alone as the primary therapy in acute-stage KD is as effective as IVIG combined with high-dose aspirin therapy. The primary endpoint is defined as CAL formation at 6-8 weeks. Patients meeting the eligibility criteria are randomly assigned (1:1) to a test group (that receives only IVIG) or a standard group (that receives IVIG plus high-dose aspirin). This clinical trial is conducted at seven medical centers in Taiwan.

Discussion: Since high-dose aspirin has significant anti-inflammatory and anti-platelet functions, it does not appear to lower the frequency of disease outcomes. Furthermore, it can decrease hemoglobin levels. Therefore, the investigators have initiated this randomized controlled trial to determine whether high-dose aspirin is necessary in the acute stage of KD.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Kawasaki Disease Center, Kaohsiung Chang Gung Memorial Hospital, Taiwan
Study Start Date : September 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kawasaki Disease
Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: IVIG only
All patients will receive IVIG (2g/kg) in 10-12 hours alone, without high-dose aspirin. After fever subsides, low-dose aspirin (3-5mg/kg/day) will be prescribed until 6-8 weeks.
Other: IVIG only
All patients will receive IVIG (2g/kg) in 10-12 hours alone, without high-dose aspirin.

Active Comparator: IVIG and Aspirin
All patients will receive IVIG (2g/kg) in 10-12 hours plus high-dose aspirin (80-100mg/kg/day, divided into four doses) till fever subside. After fever subsides, low-dose aspirin (3-5mg/kg/day) will be prescribed until 6-8 weeks.
Other: IVIG and Aspirin
All patients will receive IVIG (2g/kg) in 10-12 hours plus high-dose aspirin (80-100mg/kg/day, divided into four doses) till fever subside.




Primary Outcome Measures :
  1. coronary artery lesions [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. IVIG resistance [ Time Frame: 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Male or female, under the age of 7 years old.

2. Fulfilled the AHA criteria for KD as explained below:

  1. Fever (more than 38.0℃ ear temperature) > or = 5 days, as well as 4 of the 5 following symptoms
  2. Diffuse mucosal inflammation (strawberry tongue, dry and cracked lips)
  3. Bilateral non-purulent conjunctivitis
  4. Dysmorphous skin rashes
  5. Indurative edematous change over the hands and feet, or desquamation over the fingertips or toes
  6. Cervical lymphadenopathy (one or more nodule at least 1.5 cm in diameter)

3. An informed consent form (ICF, appendix B) signed by the patient or a legal guardian.

Exclusion Criteria:

  1. Had symptoms that did not completely match the KD criteria.
  2. Had an acute fever for < 5 days and >10 days
  3. IVIG treatment at another hospital before being referred to the study center.
  4. Treatment with corticosteroids, other than the inhaled form, in the two weeks prior to joining the study;
  5. The presence of a disease known to mimic Kawasaki disease (such as adenovirus infection, toxic shock syndrome etc.).
  6. Previous KD diagnosis.
  7. Inability to take aspirin (such as history of hypersensitivity to aspirin, G6PD deficiency, recent herpes zoster infection or vaccination, etc.)
  8. Afebrile prior to enrollment
  9. CAL prior to enrollment
  10. Severe concomitant medical disorders (e.g., immunodeficiency, chromosomal anomalies, congenital heart diseases, metabolic diseases, nephritis, collagen diseases, etc.)
  11. Suspected to have an infectious disease, including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella, and influenza
  12. Judged by the researcher to be unsuitable for this trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951234


Contacts
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Contact: Ho-Chang Kuo, MD, PhD erickuo48@yahoo.com.tw
Contact: Ying-Hsien Huang, MD, PhD yhhuang123@yahoo.com.tw

Locations
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Taiwan
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 81362
Contact: Ken-Pen Weng, MD    +886-975581955    kenpenweng@yahoo.com.tw   
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 833
Contact: Ho-Chang Kuo, MD, PhD       erickuo48@yahoo.com.tw   
Contact: Ying-Hsien Huang, MD, PhD       yhhuang123@yahoo.com.tw   
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
Contact: Ming-Chih Lin, MD    +886-917620556    mingclin@gmail.com   
Tungs' Taichung Metroharbor Hospital Recruiting
Taichung, Taiwan, 433
Contact: Chung-Chih Kao, MD    +886-935279276    cckao2cv@yahoo.com   
Linkou Chang Gung Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Chih-Jung Chen, MD       chinjung@adm.cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Ho-Chang Kuo, MD, PhD Kawasaki Disease Center, Kaohsiung Chang Gung Memorial Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02951234     History of Changes
Other Study ID Numbers: IVIG And Aspirin in KD
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Chang Gung Memorial Hospital:
coronary artery lesions
intravenous immunoglobulin
Kawasaki disease
randomized clinical trial
aspirin

Additional relevant MeSH terms:
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Vasculitis
Mucocutaneous Lymph Node Syndrome
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Aspirin
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Immunologic Factors