Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)

Dose-Ranging Pharmacodynamic Assessment of Platelet Aggregation Inhibition With Clopidogrel in Children of Blalock-Taussig Shunt Age Categories (Neonates and Infants/Toddlers)

PICOLO is a double blind placebo controlled phase II dose ranging, dose escalating study in patients of Blalock-Taussig age categories (neonates and infants/toddlers), to determine the dose providing inhibition of platelet aggregation similar to adults.

There will be 3 blinded dose groups of 12 patients each (9 active, 3 placebo), central randomization, stratified by age (< 1 month ;1 to 24 months). There will be a comparison of ADP-induced platelet aggregation at steady state.

Inclusion Criteria:

• Neonates or infants/toddlers (up to 24 months) at risk for thrombosis (e.g., Blalock-Taussig shunt or any systemic to pulmonary artery shunt, Kawasaki disease, vascular stent or any condition requiring antiplatelet therapy).

Exclusion Criteria:

• Ongoing bleeding or increased risk of bleeding

  • Weight < 2 kg; gestational age < 35 weeks
  • Allergy to drugs
  • Current or planned anticoagulant treatment
  • Unable to receive drug enterically
  • Platelet transfusion < 7days
  • Thrombocytopenia
  • Hepatic or renal failure