Kawasaki Disease Clinical Trial
Official title:
Kawasaki Disease Center, Kaohsiung Chang Gung Memorial Hospital, Taiwan
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.
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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