Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Bristol-Myers Squibb
• Treatments: Clopidogrel; Ticlopidine

Criteria

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