Phase 1
N=20
PPI and Clopidogrel Response
Drug Interaction
Bottom Line
View on ClinicalTrials.gov: NCT01170533 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Platelet Function as Assessed by the P2Y12 Reactivity Index — 56.1; 61.6; 56; 61 Percentage of platelet reactivity index
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- omeprazole and pantoprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Platelet Function as Assessed by the P2Y12 Reactivity Index |
56.1; 61.6; 56; 61; 48.8; 61.0 | — |
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 thrombosis. Patients receiving aspirin and clopidogrel are frequently treated with proton pump inhibitors, such as omeprazole or pantoprazole, in order to prevent the risk of gastrointestinal bleeding, accorded to guidelines. An interaction between proton pump inhibitors and clopidogrel has been suggested, which may lead to a decrease of clopidogrel effects. It remains unclear whether this interaction between PPIs and clopidogrel might be a class effect or if this may be affected by timing regimen.
The objectives of this two-phase investigation are:
1. to compare clopidogrel platelet inhibitory effects when taken at the same time versus separated at least 8 hours from omeprazole administration.
2. to compare clopidogrel-induced inhibitory effects when taken at the same time versus staggered at least 8 hours from pantoprazole administration.
Eligibility Criteria
Inclusion Criteria
- Healthy volunteers aged between 18 and 75 years
Exclusion Criteria
- Known allergies to clopidogrel or omeprazole.
- Blood dyscrasia or bleeding diathesis.
- Recent antiplatelet treatment ( 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
Data sourced from ClinicalTrials.gov (NCT01170533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.