Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)

This study has been completed.
Bristol-Myers Squibb
Information provided by:
Sanofi Identifier:
First received: June 21, 2005
Last updated: March 24, 2009
Last verified: March 2009
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.

Condition Intervention Phase
Congenital Heart Defects
Blood Platelet Disorders
Drug: Clopidogrel (SR25990)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Dose-Ranging Pharmacodynamic Assessment of Platelet Aggregation Inhibition With Clopidogrel in Children of Blalock-Taussig Shunt Age Categories (Neonates and Infants/Toddlers)

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percent inhibition of maximum extent and rate of aggregation of 5 µM ADP-induced platelet aggregation

Secondary Outcome Measures:
  • Adverse events

Enrollment: 92
Study Start Date: January 2004
Study Completion Date: April 2006
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.

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00115375

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
Laval, Canada
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Milano, Italy
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: ICD CSD Sanofi
  More Information

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00115375     History of Changes
Other Study ID Numbers: PDY4422 
Study First Received: June 21, 2005
Last Updated: March 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:

Additional relevant MeSH terms:
Blood Platelet Disorders
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Diseases
Hematologic Diseases
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses processed this record on February 09, 2016