Investigation of Drug-Drug Interaction Between Clopidogrel and Fluoxetine
Information source: Centre Hospitalier Universitaire de Saint Etienne
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Clopidogrel then fluoxetine+clopidogrel (Drug); Fluoxetine+clopidogrel then clopidogrel (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Centre Hospitalier Universitaire de Saint Etienne Official(s) and/or principal investigator(s):
Pierre GARNIER, MD, Principal Investigator, Affiliation: CHU de Saint-Etienne
Overall contact:
Pierre GARNIER, MD, Phone: +33 (0)4 77 12 77 88, Email: pierre.garnier@chu-st-etienne.fr
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.
Clinical Details
Official title: Investigation of Drug-Drug Interaction Between Clopidogrel and Fluoxetine
Study design: Other, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Platelet aggregation inhibition measured by optical aggregometry in presence of adenosine diphosphate (ADP) 20 μmol/L and 5 μmol/L.
Secondary outcome: Level of phosphorylated VASP (vasodilator- stimulated phosphoprotein), a good index of P2Y12 activity (platelet receptor of clopidogrel) and P-selectin by flow cytometry.Determination of clopidogrel and its metabolites in plasma by LC/MS-MS method
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Signed an informed consent
- Body mass: 60 to 85 Kg
- Platelet count: 180 to 350 G/L
- % platelet aggregation > 70%
- Subjects are to be in good health as determined by a medical history, physical
examination including vital signs, and clinical laboratory test results including
liver function, renal and full blood count
Exclusion Criteria:
- Subject with an history of seizure disorder
- Subject with a known allergy fluoxetine or clopidogrel
- Cigarette smoking
- Subject with a history of hemorrhagic disease
- Peptic ulcer
- Psychiatric disorders
- Participation in another clinical or device trial within the three previous months
- Subject who is currently taking medications
- Subject who is currently taking medications for depression
- Subject with an history of depression (MADRS score < 15)
- Hepatic insufficiency
Locations and Contacts
Pierre GARNIER, MD, Phone: +33 (0)4 77 12 77 88, Email: pierre.garnier@chu-st-etienne.fr
Service de Medecin Interne et Therapeutique Unite de Recherche Clinique Groupe de Recherche sur la Thrombose (EA3065), Saint-Etienne 42055, France
Additional Information
Starting date: March 2009
Ending date: November 2009
Last updated: October 29, 2008
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