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Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)

Primary Purpose

Congenital Heart Defects, Blood Platelet Disorders

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Clopidogrel (SR25990)
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Defects focused on measuring THROMBOSIS, PLATELET AGGREGATION, Pediatrics

Eligibility Criteria

undefined - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse events

Full Information

First Posted
June 21, 2005
Last Updated
March 24, 2009
Sponsor
Sanofi
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00115375
Brief Title
Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)
Official Title
Dose-Ranging Pharmacodynamic Assessment of Platelet Aggregation Inhibition With Clopidogrel in Children of Blalock-Taussig Shunt Age Categories (Neonates and Infants/Toddlers)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi
Collaborators
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Defects, Blood Platelet Disorders
Keywords
THROMBOSIS, PLATELET AGGREGATION, Pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Clopidogrel (SR25990)
Primary Outcome Measure Information:
Title
Percent inhibition of maximum extent and rate of aggregation of 5 µM ADP-induced platelet aggregation
Secondary Outcome Measure Information:
Title
Adverse events

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Diegem
Country
Belgium
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis Administrative Office
City
Milano
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
18195173
Citation
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.
Results Reference
result
PubMed Identifier
21106014
Citation
Pasquali 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.
Results Reference
derived

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Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)

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