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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin-omeprazole | Experimental | Rosuvastatin-omeprazole |
|
| Rosuvastatin-pantoprazole | Experimental | Rosuvastatin 20 mg for 1 month, then rosuvastatin 20 mg and pantoprazole 40 mg for 11 months |
|
| Rosuvastatin-esomeprazole | Experimental | Rosuvastatin 20 mg for 1 month, then rosuvastatin 20 mg and esomeprazole 40 mg for 11 months |
|
| Rosuvastatin-ranitidine | Active Comparator | Rosuvastatin 20 mg for 1 month, then rosuvastatin 20 mg and ranitidine 300 mg for 11 months |
|
| Atorvastatin-omeprazole | Experimental | Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and omeprazole 20 mg for 11 months |
|
| Atorvastatin-pantoprazole |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin-omeprazole | Drug | Rosuvastatin 20 mg for 1 month. Then rosuvastatin 20mg and omeprazole 20mg for 11 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in residual platelet aggregation by light transmittance aggregometry and percent change in platelet reactivity index by VASP | At 30 and 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Resistance to clopidogrel by light transmittance aggregometry (defined by RPA >55%), resistance to clopidogrel by vasodilator-stimulated phosphoprotein (VASP) (defined by PRI >55%) | 30 and 60 days | |
| Prevalence and role of CYP 2C19*2 polymorphism on the effect of PPIs and statins on the antiplatelet activity of clopidogrel |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Pierre Dery, MD, MHS | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Universitaire de Cardiologie et de Pneumologie de Quebec | Québec | Quebec | G1V4G5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26815196 | Derived | Harvey A, Modak A, Dery U, Roy M, Rinfret S, Bertrand OF, Larose E, Rodes-Cabau J, Barbeau G, Gleeton O, Nguyen CM, Proulx G, Noel B, Roy L, Paradis JM, De Larochelliere R, Dery JP. Changes in CYP2C19 enzyme activity evaluated by the [(13)C]-pantoprazole breath test after co-administration of clopidogrel and proton pump inhibitors following percutaneous coronary intervention and correlation to platelet reactivity. J Breath Res. 2016 Jan 27;10(1):017104. doi: 10.1088/1752-7155/10/1/017104. |
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Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and pantoprazole 40mg for 11 months |
|
| Atorvastatin-esomeprazole | Experimental | Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and esomeprazole 40 mg for 11 months |
|
| Atorvastatin-ranitidine | Active Comparator | Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and ranitidine 300mg for 11 months |
|
| Rosuvastatin-pantoprazole | Drug | Rosuvastatin 20 mg for 1 month, then rosuvastatin 20 mg and pantoprazole 40 mg for 11 months |
|
| Rosuvastatin-esomeprazole | Drug | Rosuvastatin 20 mg for 1 month, then rosuvastatin 20 mg and esomeprazole 40 mg for 11 months |
|
| Rosuvastatin-ranitidine | Drug | Rosuvastatin 20 mg for 1 month, then rosuvastatin 20 mg and ranitidine 300mg for 11 months |
|
| Atorvastatin-omeprazole | Drug | Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and omeprazole 20 mg for 11 months |
|
| Atorvastatin-pantoprazole | Drug | Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and pantoprazole 40 mg for 11 months |
|
| Atorvastatin-esomeprazole | Drug | Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and esomeprazole 40 mg for 11 months |
|
| Atorvastatin-ranitidine | Drug | Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and ranitidine 300mg for 11 months |
|
| 30 and 60 days |
| The composite of death from all causes, myocardial infarction, ischemia-driven repeat revascularization, and stroke | 30 days, 60 days and 1 year |
| Need to stop any antiplatelet medication for gastrointestinal bleeding or peptic ulcer disease | 30 days, 60 days and one year |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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