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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

Tracking Information
First Submitted Date  ICMJE August 8, 2008
First Posted Date  ICMJE August 11, 2008
Last Update Posted Date March 25, 2013
Study Start Date  ICMJE February 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of Drug-drug Interaction Between Clopidogrel and Fluoxetine
Official Title  ICMJE Investigation of Drug-drug Interaction Between Clopidogrel and Fluoxetine
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: 1
    Clopidogrel then fluoxetine+clopidogrel
    Intervention: Drug: Clopidogrel then fluoxetine+clopidogrel
  • Active Comparator: 2
    Fluoxetine+clopidogrel then clopidogrel
    Intervention: Drug: Fluoxetine+clopidogrel then clopidogrel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2009)
10
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2008)
12
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00732290
Other Study ID Numbers  ICMJE 0801068
2008-004395-46
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Saint Etienne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pierre GARNIER, MD CHU de Saint-Etienne
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP