drugset / Trial / NCT00930670
Evaluation of the Influence of Statins and Proton Pump Inhibitors on Clopidogrel Antiplatelet Effects
Phase 4
Completed
320 enrolled
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
RandomizedFactorialOpen-labelTreatment
Summary
There is conflicting evidence in the literature suggesting that the use of proton pump inhibitors (PPIs), and/or some statins can interfere with clopidogrel antiplatelet effect and result in adverse cardiovascular outcomes in patients treated with coronary artery stents and dual antiplatelet therapy. The primary aim of the study is to determine the effect of various currently used PPI on platelet aggregation in patients undergoing percutaneous coronary intervention (PCI) and treated with dual antiplatelet therapy. The secondary aim of the study is to evaluate how statins and 2C19\*2 polymorphism modulate the effect of PPI on clopidogrel efficacy.
Timeline
- Start
- 2009-06
- Primary completion
- 2011-12
- Completion
- 2011-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 80 mg | — |
| Subject | Esomeprazole | Small molecule | 40 mg | — |
| Subject | Omeprazole | Other / unclassified | 20 mg | — |
| Subject | Pantoprazole | Other / unclassified | 40 mg | — |
| Comparator | Ranitidine | Unknown | 300 mg | — |
| Subject | Rosuvastatin | Small molecule | 20 mg | — |