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Investigation of Drug-drug Interaction Between Clopidogrel and Fluoxetine

Information source: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov processed this data on August 23, 2015
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: Completed

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

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: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)

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

Service de Medecin et Therapeutique, Unite de Recherche Clinique Groupe de Recherche sur la Thrombose (EA3065), Saint-Etienne 42055, France
Additional Information

Starting date: February 2009
Last updated: March 22, 2013

Page last updated: August 23, 2015

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