NCT00930670

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Rosuvastatin-omeprazole	Rosuvastatin 20 mg for 1 month. Then rosuvastatin 20mg and omeprazole 20mg for 11 months
DRUG	Rosuvastatin-pantoprazole	Rosuvastatin 20 mg for 1 month, then rosuvastatin 20 mg and pantoprazole 40 mg for 11 months
DRUG	Rosuvastatin-esomeprazole	Rosuvastatin 20 mg for 1 month, then rosuvastatin 20 mg and esomeprazole 40 mg for 11 months
DRUG	Rosuvastatin-ranitidine	Rosuvastatin 20 mg for 1 month, then rosuvastatin 20 mg and ranitidine 300mg for 11 months
DRUG	Atorvastatin-omeprazole	Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and omeprazole 20 mg for 11 months
DRUG	Atorvastatin-pantoprazole	Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and pantoprazole 40 mg for 11 months
DRUG	Atorvastatin-esomeprazole	Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and esomeprazole 40 mg for 11 months
DRUG	Atorvastatin-ranitidine	Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and ranitidine 300mg for 11 months

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2009-06-30
• Last updated: 2012-02-09

Locations

1 site across 1 country: Canada