Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)

Sanofi92 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Congenital Heart Defects Blood Platelet Disorders

Interventions

Clopidogrel (SR25990)DRUG

Eligibility

Sex: ALLMax age: 24 Months

Medical Language ↔ Plain English

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

Locations (6)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Diegem, Belgium

Sanofi-Aventis Administrative Office

Laval, Canada

Sanofi-Aventis Administrative Office

Paris, France

Outcomes

Primary Outcomes

Percent inhibition of maximum extent and rate of aggregation of 5 µM ADP-induced platelet aggregation

Secondary Outcomes

Adverse events

Data from ClinicalTrials.gov

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