Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)

Sanofi

Status and phase: Completed; Phase 2

Conditions: Congenital Heart Defects; Blood Platelet Disorders

Treatments: Drug: Clopidogrel (SR25990)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00115375

PDY4422

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: Under 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind