Clinical Trial: A Multi-center, Randomized to Compare the Efficacy of IVIG Alone and IVIG Plus High-dose Aspirin in Kawasaki Disease
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Kawasaki Disease Center, Kaohsiung Chang Gung Memorial Hospital, Taiwan
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.
Detailed Summary:
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.
Sponsor: Chang Gung Memorial Hospital
Current Primary Outcome: coronary artery lesions [ Time Frame: 8 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: IVIG resistance [ Time Frame: 7 days ]
Original Secondary Outcome: Same as current
Information By: Chang Gung Memorial Hospital
Dates:
Date Received: October 28, 2016
Date Started: September 2016
Date Completion: August 2019
Last Updated: November 3, 2016
Last Verified: September 2016
