Blood Platelet Disorders, Congenital Heart Defects
Conditions
Keywords
THROMBOSIS, PLATELET AGGREGATION, Pediatrics
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
Bristol-Myers Squibb
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent inhibition of maximum extent and rate of aggregation of 5 µM ADP-induced platelet aggregation | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Countries
Belgium, Canada, France, Germany, Italy, United States
Outcome results
None listed