drugset / Trial / NCT00930670

Evaluation of the Influence of Statins and Proton Pump Inhibitors on Clopidogrel Antiplatelet Effects

NCT00930670

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

EvaluationDrugModalityDoseRoute
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