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NCT01170533 · ClinicalTrials.gov registry record · Phase 1
PPI and Clopidogrel Response
A Phase 1 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01170533 is a Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 20 participants.
The verdict
NCT01170533, a Phase 1 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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.
Interventions
- DRUG omeprazole and pantoprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01170533
The ClinicalTrials.gov registry entry for NCT01170533 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which omeprazole and pantoprazole is the first listed.
NCT01170533 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01170533 about?
NCT01170533 is a clinical study titled "PPI and Clopidogrel Response". 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, su...
What is the current status of trial NCT01170533?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2009-03. Estimated completion is 2010-08.
What interventions are being tested in trial NCT01170533?
The interventions under investigation include: omeprazole and pantoprazole (DRUG).
Who is sponsoring clinical trial NCT01170533?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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