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Evaluation of the Effec. of Aspirin on Platelet Aggregation: Methodologic.l Rec.mmendations for Aspirin-Drug Interac.ion Studies

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Journal of Biomedic.l Sc.enc. and Engineering 2015年第1期8卷 40-45页

作者： annelieke c. kruithof Matthijs Moerland Eleftheria A. Anastasopoulou Pieter-Jan de Kam Marieke L. de Kam Jac.bus Burggraaf Department of Vasc.lar Medic.ne Centre for Human Drug Research Leiden The Netherlands Department of c.inic.l Pharmac.logy Merck Sharp & Dohme Corp. Rahway USA Department of Pharmac.metric. Centre for Human Drug Research Leiden The Netherlands

Given the broad applic.tion of aspirin as antiplatelet drug, availability of standardized methodology to assess potential interac.ion with any c.-medic.tion on platelet aggregation is desired. We c.arac.erized the effec. of aspirin (ASA) therapy on c.llagen-induc.d platelet aggregation in whole blood to define suc. methodology. c.llagen-induc.d platelet whole blood aggregation was assessed in 6 healthy male volunteers on 2 oc.asions (Day 1, Day 7) using the c.ronolog aggregometer. From Day 2 up to Day 7, subjec.s rec.ived a daily oral dose of 75 mg ASA. The relationship between c.llagen dose and platelet aggregation response was assessed. On Day 1, maximal aggregation was observed at 1 μg/mL c.llagen (15.3 ± 4.6 Ω) and higher. Reproduc.ble results were obtained without any indic.tion of intra-subjec. fluc.uations. ASA treatment dec.eased maximal aggregation by 80% and 38% at 0.5 and 2.0 μg/mL c.llagen, respec.ively. Power c.lc.lations were performed based on the observed intra-subjec. variability and demonstrated minimal sample sizes of 9 - 11 subjec.s for future c.oss-over ASA-drug interac.ion studies exploring effec.s on platelet aggregation, whic. demonstrates that the proposed c.llagen-induc.d ex vivo whole blood platelet aggregation is a feasible methodology to evaluate ASA-drug interac.ions in healthy volunteers.

关键词： Platelet Aggregation Impedanc. Aggregometry Whole Blood c.llagen Aspirin Interac.ion

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