Status:
COMPLETED
PPI and Clopidogrel Response
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Bristol-Myers Squibb
Sanofi
Conditions:
Drug Interaction
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Clopidogrel, in combination with aspirin, is currently the recommended treatment for secondary prevention of ischemic events in high-risk patients and for prevention of coronary artery stent thrombosi...
Detailed Description
Clopidogrel, in combination with aspirin, is currently the recommended treatment for secondary prevention of ischemic events in high-risk patients and for prevention of coronary artery stent thrombosi...
Eligibility Criteria
Inclusion
- Healthy volunteers aged between 18 and 75 years
Exclusion
- Known allergies to clopidogrel or omeprazole.
- Blood dyscrasia or bleeding diathesis.
- Recent antiplatelet treatment (\< 30 days) with a glycoprotein IIb/IIIa antagonist, thienopyridine (ticlopidine, clopidogrel), cilostazol or dipyridamole.
- Treatment with other medications that may interfere with the CYP system (ketoconazole, itraconazole, diltiazem, erythromycin, clarithromycin, fluvoxamine, fluoxetine, nefazodone, or sertraline).
- Platelet count \<100x106/microL.
- Diabetes mellitus
- History of coronary artery disease, gastrointestinal bleed, gastroesophageal reflux disease (GERD), cerebrovascular event or any active malignancy.
- Active bleeding or hemodynamic instability.
- Serum creatinine \>2mg/dL.
- Baseline ALT \>2.5 times the upper limit of normal.
- Pregnant females.
- Patients taking omeprazole or any H2 antagonist or proton pump inhibitors
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01170533
Start Date
March 1 2009
End Date
August 1 2010
Last Update
March 6 2012
Active Locations (1)
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1
University of Florida
Jacksonville, Florida, United States, 32209