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Completed

NCT Number: NCT00732290

Investigation of Drug-drug Interaction Between Clopidogrel and Fluoxetine

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.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Service de Medecin et Therapeutique, Unite de Recherche Clinique Groupe de Recherche sur la Thrombose (EA3065)

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clopidogrel then fluoxetine+clopidogrel

Drug

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

Fluoxetine+clopidogrel then clopidogrel

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: PLATINE

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 11, 2008
Registry last updated
Mar 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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