PPI and Clopidogrel Response

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Florida
• Collaborators: Bristol-Myers Squibb; Sanofi
• Treatments: Clopidogrel; Omeprazole; Pantoprazole; Ticlopidine

Criteria

Inclusion Criteria:

• Healthy volunteers aged between 18 and 75 years

Exclusion Criteria:

1. Known allergies to clopidogrel or omeprazole.

2. Blood dyscrasia or bleeding diathesis.

3. Recent antiplatelet treatment (< 30 days) with a glycoprotein IIb/IIIa antagonist, thienopyridine (ticlopidine, clopidogrel), cilostazol or dipyridamole.

4. Treatment with other medications that may interfere with the CYP system (ketoconazole, itraconazole, diltiazem, erythromycin, clarithromycin, fluvoxamine, fluoxetine, nefazodone, or sertraline).

5. Platelet count <100x106/microL.

6. Diabetes mellitus

7. History of coronary artery disease, gastrointestinal bleed, gastroesophageal reflux disease (GERD), cerebrovascular event or any active malignancy.

8. Active bleeding or hemodynamic instability.

9. Serum creatinine >2mg/dL.

10. Baseline ALT >2.5 times the upper limit of normal.

11. Pregnant females.

12. Patients taking omeprazole or any H2 antagonist or proton pump inhibitors