Investigation of Drug-drug Interaction Between Clopidogrel and Fluoxetine (PLATINE)
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ClinicalTrials.gov Identifier: NCT00732290 |
Recruitment Status
:
Completed
First Posted
: August 11, 2008
Last Update Posted
: March 25, 2013
|
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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 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 |

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
|
- 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 ]
- 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 ]
- Determination of clopidogrel and its metabolites in plasma by LC/MS-MS method [ Time Frame: During clopidogrel taking ]

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

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
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: | Centre Hospitalier Universitaire de Saint Etienne |
ClinicalTrials.gov Identifier: | NCT00732290 History of Changes |
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:
Clopidogrel Ticlopidine Fluoxetine 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 Fibrinolytic Agents |
Fibrin Modulating Agents Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Serotonin Agents Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Cytochrome P-450 CYP2D6 Inhibitors |