Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)

Phase 2

Completed

• Conditions: Congenital Heart Defects; Blood Platelet Disorders

• Registration Number: NCT00115375
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-06-21
• Study First Submitted QC: 2005-06-21
• Study First Posted: 2005-06-22
• Study Completion: 2006-04
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse events

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇮🇹 Milano, Italy