Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)

Congenital Heart Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115375
• Other study ID #: PDY4422
• Status: Completed
• Phase: Phase 2
• First received: June 21, 2005
• Last updated: March 24, 2009
• Start date: January 2004
• Est. completion date: April 2006

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Platelet Disorders
• Congenital Heart Defects
• Heart Defects, Congenital

Intervention

Drug:
• Clopidogrel (SR25990)

Locations

Country	Name	City	State
Belgium	Sanofi-Aventis Administrative Office	Diegem
Canada	Sanofi-Aventis Administrative Office	Laval
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Italy	Sanofi-Aventis Administrative Office	Milano
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Italy, 

References & Publications (1)

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 Pl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent inhibition of maximum extent and rate of aggregation of 5 µM ADP-induced platelet aggregation
Secondary	Adverse events