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Sponsored by: |
Centre Hospitalier Universitaire de Saint Etienne |
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Information provided by: | Centre Hospitalier Universitaire de Saint Etienne |
ClinicalTrials.gov Identifier: | NCT00732290 |
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.
Condition | Intervention | Phase |
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Healthy |
Drug: Clopidogrel then fluoxetine+clopidogrel Drug: Fluoxetine+clopidogrel then clopidogrel |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Investigation of Drug-Drug Interaction Between Clopidogrel and Fluoxetine |
Enrollment: | 10 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Clopidogrel then fluoxetine+clopidogrel
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Drug: Clopidogrel then fluoxetine+clopidogrel
D1 : clopidogrel (Plavix) 600mg (8 tablets) one time D45 to D48 : Fluoxetine (Fluoxetine EG 20mg) 20mg (1 tablet) per day D49 : 20mg Fluoxetine + 600mg Clopidogrel
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2: Active Comparator
Fluoxetine+clopidogrel then clopidogrel
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Drug: Fluoxetine+clopidogrel then clopidogrel
D1 to D4 : Fluoxetine (Fluoxetine EG 20mg) 20mg (1 tablet) per day D5: 20mg Fluoxetine + Clopidogrel (Plavix) 600mg (8 tablets) one time D49 : Clopidogrel 600mg one time
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Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
France | |
Service de Medecin et Therapeutique, Unite de Recherche Clinique Groupe de Recherche sur la Thrombose (EA3065) | |
Saint-Etienne, France, 42055 |
Principal Investigator: | Pierre GARNIER, MD | CHU de Saint-Etienne |
Responsible Party: | CHU de Saint-Etienne ( Françoise LORCA ) |
Study ID Numbers: | 2008-004395-46, 0801068 |
Study First Received: | August 8, 2008 |
Last Updated: | March 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00732290 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency; France: French Data Protection Authority |
Healthy volunteer Pharmacokinetic pharmacodynamic Polymorphism, Genetic |
Fluoxetine Neurotransmitter Agents Clopidogrel Psychotropic Drugs Platelet Aggregation Inhibitors |
Healthy Antidepressive Agents, Second-Generation Serotonin Uptake Inhibitors Antidepressive Agents Serotonin |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hematologic Agents Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors Pharmacologic Actions |
Fluoxetine Serotonin Agents Therapeutic Uses Clopidogrel Platelet Aggregation Inhibitors Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |