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.
- 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).
- 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
- Hepatic or renal failure