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
|Condition or disease||Intervention/treatment||Phase|
|Kawasaki Disease||Other: IVIG only Other: IVIG and Aspirin||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||278 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- coronary artery lesions [ Time Frame: 8 weeks ]
- IVIG resistance [ Time Frame: 7 days ]
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
|Contact: Ho-Chang Kuo, MD, PhDfirstname.lastname@example.org|
|Contact: Ying-Hsien Huang, MD, PhDemail@example.com|
|Kaohsiung Veterans General Hospital||Recruiting|
|Kaohsiung, Taiwan, 81362|
|Contact: Ken-Pen Weng, MD +886-975581955 firstname.lastname@example.org|
|Kaohsiung Chang Gung Memorial Hospital||Recruiting|
|Kaohsiung, Taiwan, 833|
|Contact: Ho-Chang Kuo, MD, PhD email@example.com|
|Contact: Ying-Hsien Huang, MD, PhD firstname.lastname@example.org|
|Taichung Veterans General Hospital||Recruiting|
|Taichung, Taiwan, 40705|
|Contact: Ming-Chih Lin, MD +886-917620556 email@example.com|
|Tungs' Taichung Metroharbor Hospital||Recruiting|
|Taichung, Taiwan, 433|
|Contact: Chung-Chih Kao, MD +886-935279276 firstname.lastname@example.org|
|Linkou Chang Gung Memorial Hospital||Recruiting|
|Contact: Chih-Jung Chen, MD email@example.com|
|Principal Investigator:||Ho-Chang Kuo, MD, PhD||Kawasaki Disease Center, Kaohsiung Chang Gung Memorial Hospital|