Ignite Creation Date:
2024-05-05 @ 9:38 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00930670
Status:
COMPLETED
Last Update Posted:
2012-02-09
First Post:
2009-06-29
Brief Title:
Evaluation of the Influence of Statins and Proton Pump Inhibitors on Clopidogrel Antiplatelet Effects
Sponsor:
Centre de Recherche de lInstitut Universitaire de Cardiologie et de Pneumologie de Quebec
Organization:
Institut universitaire de cardiologie et de pneumologie de Québec University Laval
Study Overview
Official Title:
Evaluation of the Influence of Statins and Proton Pump Inhibitors on Clopidogrel Antiplatelet Effects
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPICE
Brief Summary:
There is conflicting evidence in the literature suggesting that the use of proton pump inhibitors PPIs andor 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 2C192 polymorphism modulate the effect of PPI on clopidogrel efficacy
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 2C192 polymorphism modulate the effect of PPI on clopidogrel efficacy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None