HealthyPhase 1PLATINENCT00732290
Investigation of Drug-drug Interaction Between Clopidogrel and Fluoxetine
A Phase 1 study testing Clopidogrel then fluoxetine+clopidogrel and Fluoxetine+clopidogrel then clopidogrel in people with Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Clopidogrel then fluoxetine+clopidogrel and Fluoxetine+clopidogrel then clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to May 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Medecin et Therapeutique, Unite de Recherche Clinique Groupe de Recherche sur la Thrombose (EA3065)
Saint-Etienne, 42055
About this study
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.
- Conditions
- Healthy
- Being tested
- Clopidogrel then fluoxetine+clopidogrel, Fluoxetine+clopidogrel then clopidogrel
- Keywords
- Healthy volunteer, Pharmacokinetic, pharmacodynamic, Polymorphism, Genetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel then fluoxetine+clopidogrelDrug
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 clopidogrelDrug
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 group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Clopidogrel then fluoxetine+clopidogrel Receives: Drug: Clopidogrel then fluoxetine+clopidogrel |
| 2 | Active comparator | Fluoxetine+clopidogrel then clopidogrel Receives: Drug: Fluoxetine+clopidogrel then clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet aggregation inhibition measured by optical aggregometry in presence of adenosine diphosphate (ADP) 20 μmol/L and 5 μmol/L.
Measured: Before first fluoxetin taking, during clopidogrel taking
Secondary outcomes (2)
Level of phosphorylated VASP (vasodilator- stimulated phosphoprotein), a good index of P2Y12 activity (platelet receptor of clopidogrel) and P-selectin by flow cytometry.
Measured: Before first Fluoxetine taking and during Clopidogrel taking
Determination of clopidogrel and its metabolites in plasma by LC/MS-MS method
Measured: During clopidogrel taking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startFeb 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre GARNIER, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732290
- Sponsor's protocol ID
- 0801068
- Other IDs
- 2008-004395-46, 2008
- Acronym
- PLATINE
- Status last verified
- Mar 2013
- First submitted
- 8 Aug 2008
- Last updated
- 25 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Drug-drug Interaction Between Clopidogrel and Fluoxetine
- ClinicalTrials.gov ID
- NCT00732290
- Acronym / sponsor ID
- PLATINE / 0801068
- Conditions
- Healthy
- Keywords
- Healthy volunteer, Pharmacokinetic, pharmacodynamic, Polymorphism, Genetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Clopidogrel then fluoxetine+clopidogrelClopidogrel then fluoxetine+clopidogrel |
| 2 | Active comparator | Drug: Fluoxetine+clopidogrel then clopidogrelFluoxetine+clopidogrel then clopidogrel |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clopidogrel then fluoxetine+clopidogrelD1 : 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 | 1 |
| Fluoxetine+clopidogrel then clopidogrelD1 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 | Drug | 2 |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre GARNIER, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clopidogrel then fluoxetine+clopidogrel and Fluoxetine+clopidogrel then clopidogrel in people with Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2013.