Efficacy of Primary Treatment With Immunoglobulin Plus Infliximab for the Early Regression of Coronary Artery Lesion in Kawasaki Disease: a Multicenter, Open-label, Blinded-end Randomized Controlled Study.

NCT04535518 Phase 3 WITHDRAWN

This study evaluates the efficacy of the addition of infliximab to conventional initial treatment (intravenous immunoglobulin \[IVIG\] plus aspirin) in early regression of coronary artery lesion in patients with Kawasaki disease (KD).

Details

Lead sponsor	Children's Hospital of Fudan University
Phase	Phase 3
Status	WITHDRAWN
Start date	2020-10
Completion	2022-09

Conditions

• Kawasaki Disease

Interventions

• IVIG
• Aspirin
• Infliximab

Primary outcomes

• Percentage of the regression of coronary artery lesion (CAL) at one month of illness — at one month of illness
  The regression of CAL is defined as z \< 2 of all coronary arteries of LMCA, LAD, LCX, and the proximal and middle segment of the RCA.Two-dimensional echocardiography will be performed to evaluate CAL at 1 month of illness. The measurement of each patient included the diameter of the left main coronary artery (LMCA), the left anterior descending artery (LAD), the left circumflex coronary artery (LCX), and the proximal and middle segments of the right coronary artery (RCA). Z score of each coronary artery will be calculated (Journal of the American Society of Echocardiography, 2011, 24(1):60-74).

Countries

China