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dc.contributor.authorLi, Jennifer S.
dc.contributor.authorYow, Eric
dc.contributor.authorBerezny, Katherine Y.
dc.contributor.authorBokesch, Paula M.
dc.contributor.authorTalajasjo, Matsato
dc.contributor.authorGraham, Thomas P. Jr.
dc.contributor.authorSanders, Stephen P.
dc.contributor.authorSidi, Daniel
dc.contributor.authorBonnet, Damien
dc.contributor.authorEwert, Peter
dc.contributor.authorJennings, Lisa K.
dc.contributor.authorMichelson, Alan D.
dc.date2022-08-11T08:10:10.000
dc.date.accessioned2022-08-23T16:58:08Z
dc.date.available2022-08-23T16:58:08Z
dc.date.issued2008-01-29
dc.date.submitted2012-04-25
dc.identifier.citationCirculation. 2008 Jan 29;117(4):553-9. Epub 2008 Jan 14. doi 10.1161/CIRCULATIONAHA.107.715821
dc.identifier.issn0009-7322 (Linking)
dc.identifier.doi10.1161/CIRCULATIONAHA.107.715821
dc.identifier.pmid18195173
dc.identifier.urihttp://hdl.handle.net/20.500.14038/43299
dc.description.abstractBACKGROUND: Infants and young children with certain types of heart disease are at increased risk for thromboses. Clopidogrel 75 mg/d is used in adults to prevent thrombotic events. The dose to achieve similar platelet inhibition in children is unknown. The objectives of the present study were (1) to determine the dose of clopidogrel needed in infants and young children to achieve a mean 30% to 50% inhibition of 5-micromol/L ADP-induced platelet aggregation (ie, inhibition similar to that observed with 75 mg in adults) and (2) to assess the safety and tolerability of clopidogrel in infants and young children. METHODS AND RESULTS: We performed a prospective, multicenter, randomized, placebo-controlled trial evaluating the pharmacodynamics of clopidogrel in children (0 to 24 months) with a cardiac condition at risk for arterial thrombosis. Patients were randomized to clopidogrel versus placebo in a 3:1 ratio in 4 sequential groups (0.01, 0.10, 0.20, and 0.15 mg/kg) for > or = 7 and andlt; or = 28 days. Platelet aggregation was assessed at baseline and steady state by light-transmission aggregometry. Of 116 patients enrolled, 92 (50% neonates, 50% infants/toddlers) were randomized, and 73 completed the study. A total of 79% of the randomized and treated patients were taking aspirin. Compared with placebo, clopidogrel 0.20 mg x kg(-1) x d(-1) resulted in a mean 49.3% (95% confidence interval 25.7% to 72.8%) inhibition of the maximum extent of platelet aggregation and a mean 43.9% (95% confidence interval 18.6% to 69.2%) inhibition of the rate of platelet aggregation. There was marked interpatient variability in the degree of platelet aggregation inhibition within each treatment-dose group and age group. No serious bleeding events occurred. CONCLUSIONS: Clopidogrel 0.20 mg x kg(-1) x d(-1) in children 0 to 24 months of age achieves a platelet inhibition level similar to that in adults taking 75 mg/d. Clopidogrel is well tolerated in infants and young children at this dose.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=18195173&dopt=Abstract">Link to article in PubMed</a>
dc.relation.urlhttp://dx.doi.org/10.1161/CIRCULATIONAHA.107.715821
dc.subjectAspirin
dc.subjectDose-Response Relationship, Drug
dc.subjectHemorrhage
dc.subjectHumans
dc.subjectInfant
dc.subjectInfant, Newborn
dc.subjectPlatelet Aggregation
dc.subjectPlatelet Aggregation Inhibitors
dc.subjectTiclopidine
dc.subjectHematology
dc.subjectOncology
dc.subjectPediatrics
dc.titleDosing of clopidogrel for platelet inhibition in infants and young children: primary results of the Platelet Inhibition in Children On cLOpidogrel (PICOLO) trial
dc.typeJournal Article
dc.source.journaltitleCirculation
dc.source.volume117
dc.source.issue4
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/peds_hematology/103
dc.identifier.contextkey2796593
html.description.abstract<p>BACKGROUND: Infants and young children with certain types of heart disease are at increased risk for thromboses. Clopidogrel 75 mg/d is used in adults to prevent thrombotic events. The dose to achieve similar platelet inhibition in children is unknown. The objectives of the present study were (1) to determine the dose of clopidogrel needed in infants and young children to achieve a mean 30% to 50% inhibition of 5-micromol/L ADP-induced platelet aggregation (ie, inhibition similar to that observed with 75 mg in adults) and (2) to assess the safety and tolerability of clopidogrel in infants and young children.</p> <p>METHODS AND RESULTS: We performed a prospective, multicenter, randomized, placebo-controlled trial evaluating the pharmacodynamics of clopidogrel in children (0 to 24 months) with a cardiac condition at risk for arterial thrombosis. Patients were randomized to clopidogrel versus placebo in a 3:1 ratio in 4 sequential groups (0.01, 0.10, 0.20, and 0.15 mg/kg) for > or = 7 and andlt; or = 28 days. Platelet aggregation was assessed at baseline and steady state by light-transmission aggregometry. Of 116 patients enrolled, 92 (50% neonates, 50% infants/toddlers) were randomized, and 73 completed the study. A total of 79% of the randomized and treated patients were taking aspirin. Compared with placebo, clopidogrel 0.20 mg x kg(-1) x d(-1) resulted in a mean 49.3% (95% confidence interval 25.7% to 72.8%) inhibition of the maximum extent of platelet aggregation and a mean 43.9% (95% confidence interval 18.6% to 69.2%) inhibition of the rate of platelet aggregation. There was marked interpatient variability in the degree of platelet aggregation inhibition within each treatment-dose group and age group. No serious bleeding events occurred.</p> <p>CONCLUSIONS: Clopidogrel 0.20 mg x kg(-1) x d(-1) in children 0 to 24 months of age achieves a platelet inhibition level similar to that in adults taking 75 mg/d. Clopidogrel is well tolerated in infants and young children at this dose.</p>
dc.identifier.submissionpathpeds_hematology/103
dc.contributor.departmentDepartment of Pediatrics
dc.source.pages553-9


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