Double the Dose of Clopidogrel or Switch to Prasugrel to Antagonize Proton Pump Inhibitor Interaction.
NCT ID: NCT01175200
Last Updated: 2012-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2010-09-30
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Prasugrel
Prasugrel
antiplatelet agent
Clopidogrel
Clopidogrel
antiplatelet agent
Lansoprazole
proton pump inhibitor
Lansoprazole
proton pum inhibitor
Placebo
Placebo
placebo comparator similar to lansoprazole
Interventions
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Clopidogrel
antiplatelet agent
Prasugrel
antiplatelet agent
Lansoprazole
proton pum inhibitor
Placebo
placebo comparator similar to lansoprazole
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Between 18 and 75 years of age
* Body Mass Index between 18 and 30 kg/m2 and body weight not less than 60 kg
* No major bleeding according to ISTH definition
* Subjects who signed an informed consent document
* Subjects who signed a separate pharmacogenomic informed consent document
* Subjects registered to the French national welfare system
Exclusion Criteria
* Use of known inhibitors or inducers of CYP2C19 and CYP3A including grape fruit juice intake
* Known hypersensitivity to lansoprazole, its excipients, or substituted benzimidazoles,
* Known hypersensitivity to clopidogrel / prasugrel
* Anti-platelet treatment other than clopidogrel + aspirin within 7 days before inclusion
* Any formal indication to maintain PPI treatment
* PPI within 15 days before inclusion in the study
* Active pathology with 10 days before inclusion
* Prior history of stent thrombosis
* Prior history of Stroke
* Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
18 Years
75 Years
ALL
No
Sponsors
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Groupe Hospitalier Pitie-Salpetriere
OTHER
Medco Health Solutions, Inc.
INDUSTRY
Ascopharm Groupe Novasco
OTHER
Responsible Party
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Locations
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Pitié Salpétrière Hospital
Paris, , France
Countries
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Other Identifiers
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DOSAPI
Identifier Type: -
Identifier Source: org_study_id