drugset / Trial / NCT00732290

Investigation of Drug-drug Interaction Between Clopidogrel and Fluoxetine

NCT00732290

Phase 1 Completed 10 enrolled University Hospital of Saint-Etienne
RandomizedCrossoverSingle-blind

Summary

Clopidogrel is a platelet aggregation inhibitor witch prevents thrombotic events in patients with atherosclerotic vascular disease. To date, 4 to 30 % of patients are considered as poor, low or non-responder to this therapeutic. However, drug-drug interactions may lead to decrease the clopidogrel responsiveness. Many arguments are in support to a drug-drug interaction between clopidogrel and fluoxetine (selective serotonin reuptake inhibitor). On the pharmacokinetic level, fluoxetine inhibits the cytochroms involved in the production of clopidogrel active metabolite. On the pharmacodynamic level fluoxetine could increase the risk of hemorrhage by inhibiting the serotonin platelet reuptake and thus enhance the antiplatelet effect of clopidogrel. The purpose of this study is to investigate the influence of fluoxetine on pharmacokinetic and pharmacodynamic of clopidogrel.

Timeline

Start
2009-02
Primary completion
2009-05
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clopidogrel Small molecule 600 mg
Comparator Fluoxetine Small molecule 20 mg

Indications

No indication recorded.