drugset / Trial / NCT00115375
Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2004-01
- Primary completion
- —
- Completion
- 2006-04
Publications
- Results 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clopidogrel | Small molecule | 0.01 mg/kg | — |
| Subject | Clopidogrel | Small molecule | 0.1 mg/kg | — |
| Subject | Clopidogrel | Small molecule | 0.15 mg/kg | — |
| Subject | Clopidogrel | Small molecule | 0.2 mg/kg | — |