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Completed

NCT Number: NCT00115375

Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)

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.

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Key information

Conditions

Congenital Heart Defects Blood Platelet Disorders Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Embolism and Thrombosis Heart Defects, Congenital Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Thrombosis Vascular Diseases

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office, Diegem, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel (SR25990)

Drug

Primary outcomes

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

Secondary outcomes

  1. Adverse events

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

Dose-Ranging Pharmacodynamic Assessment of Platelet Aggregation Inhibition With Clopidogrel in Children of Blalock-Taussig Shunt Age Categories (Neonates and Infants/Toddlers)

Important dates

Study start
2004
Study completion
2006
First posted
Jun 22, 2005
Registry last updated
Mar 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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