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Investigation of Drug-drug Interaction Between Clopidogrel and Fluoxetine (PLATINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00732290
Recruitment Status : Completed
First Posted : August 11, 2008
Last Update Posted : March 25, 2013
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Healthy Drug: Clopidogrel then fluoxetine+clopidogrel Drug: Fluoxetine+clopidogrel then clopidogrel Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Official Title: Investigation of Drug-drug Interaction Between Clopidogrel and Fluoxetine
Study Start Date : February 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Clopidogrel then fluoxetine+clopidogrel
 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
Active Comparator: 2
Fluoxetine+clopidogrel then clopidogrel
 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


Outcome Measures
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Primary Outcome Measures :
  1. Platelet aggregation inhibition measured by optical aggregometry in presence of adenosine diphosphate (ADP) 20 μmol/L and 5 μmol/L. [ Time Frame: Before first fluoxetin taking, during clopidogrel taking ]

Secondary Outcome Measures :
  1. Level of phosphorylated VASP (vasodilator- stimulated phosphoprotein), a good index of P2Y12 activity (platelet receptor of clopidogrel) and P-selectin by flow cytometry. [ Time Frame: Before first Fluoxetine taking and during Clopidogrel taking ]
  2. Determination of clopidogrel and its metabolites in plasma by LC/MS-MS method [ Time Frame: During clopidogrel taking ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732290


Locations
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France
Service de Medecin et Therapeutique, Unite de Recherche Clinique Groupe de Recherche sur la Thrombose (EA3065)
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Pierre GARNIER, MD CHU de Saint-Etienne
More Information
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00732290    
Other Study ID Numbers: 0801068
2008-004395-46
First Posted: August 11, 2008    Key Record Dates
Last Update Posted: March 25, 2013
Last Verified: March 2013
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Healthy volunteer
Pharmacokinetic
pharmacodynamic
Polymorphism, Genetic
Additional relevant MeSH terms:
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Fluoxetine
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
 Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors