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Aspirin dosage and its effects on coronary aneurysm in Kawasaki disease: A randomized controlled trial

Aspirin dosage and its effects on coronary aneurysm in Kawasaki disease: A randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260328007
Enrollment
195
Registered
2026-03-28
Start date
2026-04-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

There are few retrospective data and one prospective showed no different in coronary artery aneurysm event outcomes between patients receiving low-, medium- and high-dose aspirin. The updated guideline state medium- and high-dose are acceptable as initial treatment. However, the prospective randomized control trial is still lacking. Kawasaki disease, aspirin

Interventions

Initial low dose aspirin with 3-5 mg/kg/day, but main treatment with IVIg and IV methylprednisolone per guideline,Initial medium dose aspirin with 30-50 mg/kg/day, but main treatment with IVIg and IV
Active Comparator Drug,Active Comparator Drug,Active Comparator Drug
Low-dose aspirin,Medium-dose aspirin,High-dose aspirin

Sponsors

No Study Secondary Sponsor
Collaborator

Eligibility

Sex/Gender
All
Age
1 Months to 18 Years

Inclusion criteria

Inclusion criteria: 1. Patients age 1 month to 18 years who diagnosed with Kawasaki disease based on AHA criteria at Siriraj hospital, Chonburi hospital, Sawanpracharak hospital, Prapokklao Chanthaburi hospital, Nakhon Pathom hospital, Khon Kaen hospital and Srinakharinwirot University hospital

Exclusion criteria

Exclusion criteria: 1. Prior Aspirin treatment from other diseases or prior aspiring prescribed in newly diagnose Kawasaki disease and received aspirin for more than 24 hours 2. Severe comorbidities or contraindications to receiving Aspirin such as liver failure, chronic kidney disease, acute renal failure, varicella or influenza co-infection, previously documented severe adverse drug reaction to NSAIDS, active upper gastrointestinal bleeding or serious bleedings 3. Afebrile prior to treat KD by IVIg and Aspirin 4. Known to have underlying of vasculitis or autoimmune diseases

Design outcomes

Primary

MeasureTime frame
Coronary arteries aneurysm 6-8 weeks Echocardiogram

Secondary

MeasureTime frame
Coronary arteries aneurysm 1 year Echocardiogram ,Fever days Days post-IVIG days

Countries

Thailand

Contacts

Public ContactChodchanok Vijarnsorn

Faculty of Medicine Siriraj Hospital

cvijarnsorn@yahoo.com0813447015

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026