Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)
Dose-Ranging Pharmacodynamic Assessment of Platelet Aggregation Inhibition With Clopidogrel in Children of Blalock-Taussig Shunt Age Categories (Neonates and Infants/Toddlers)
1 other identifier
interventional
92
6 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2004
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 21, 2005
CompletedFirst Posted
Study publicly available on registry
June 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedMarch 25, 2009
March 1, 2009
June 21, 2005
March 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent inhibition of maximum extent and rate of aggregation of 5 µM ADP-induced platelet aggregation
Secondary Outcomes (1)
Adverse events
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- Bristol-Myers Squibbcollaborator
Study Sites (6)
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807, United States
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
Milan, Italy
Related Publications (2)
Li JS, Yow E, Berezny KY, Bokesch PM, Takahashi M, Graham TP Jr, Sanders SP, Sidi D, Bonnet D, Ewert P, Jennings LK, Michelson AD; PICOLO Investigators. Dosing of clopidogrel for platelet inhibition in infants and young children: primary results of the Platelet Inhibition in Children On cLOpidogrel (PICOLO) trial. Circulation. 2008 Jan 29;117(4):553-9. doi: 10.1161/CIRCULATIONAHA.107.715821. Epub 2008 Jan 14.
PMID: 18195173RESULTPasquali SK, Yow E, Jennings LK, Li JS. Platelet activity associated with concomitant use of clopidogrel and proton pump inhibitors in children with cardiovascular disease. Congenit Heart Dis. 2010 Nov-Dec;5(6):552-5. doi: 10.1111/j.1747-0803.2010.00461.x.
PMID: 21106014DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ICD CSD
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 21, 2005
First Posted
June 22, 2005
Study Start
January 1, 2004
Study Completion
April 1, 2006
Last Updated
March 25, 2009
Record last verified: 2009-03