PICOLO Trial: Dosing of Clopidogrel in Infants and Young Children

Li, J. et al. Circulation 2008;117:553-9.

Conlcusion: Clopidogrel 0.2 mg/kg/day in children 0-24 months of age achieves a platelet inhibition similar to that of adults with 75 mg/day.

Method:
Prospective, multicenter, randomized, placebo-controlled trial.
n=73 (50% neonates, 50% rest)
Randomized to Clopidogrel vs. Placebo in 3:1 in sequential groups.
Doses used were: 0.01 mg/kg, 0.1 mg/kg, 0.2 mg/kg, and 0.15 mg/kg. Given for 7-28 days.
Platelet aggregation was assessed by Light-Transmission Aggregometry (Maximal extent of platelet aggregation and rate of aggregation were calculated). 30-50% inhibition of 5-microMol/L ADP-induced platelet aggregation is taken as therapeutic range (similar to adults on 75 mg/day).

0.20 mg/kg daily achieved a mean of 49.3% inhibition of maximum extent of aggregation & 43.9% inhibition of rate of aggregation. Marked interpatient variability in inhibition achieved was noted within each group.