Ignite Creation Date:
2024-05-05 @ 9:43 PM
Last Modification Date:
2024-10-26 @ 10:08 AM
Study NCT ID:
NCT00950339
Status:
COMPLETED
Last Update Posted:
2016-07-07
First Post:
2009-04-19
Brief Title:
Platelet Inhibitory Effect of Clopidogrel in Patients Treated With Omeprazole Pantoprazole or Famotidine
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
Platelet Inhibitory Effect of Clopidogrel in Patients Treated With Omeprazole Pantoprazole or Famotidine
Status:
COMPLETED
Status Verified Date:
2016-07
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:
None
Brief Summary:
Current guidelines recommend the addition of proton pump inhibitors PPI to patients taking double anti-platelet therapy Aspirin and Clopidogrel to prevent upper GI bleeding1 Many post percutaneous coronary intervention PCI patients are treated with dual anti-platelet medications as well as PPI to prevent upper GI bleeding
Recently it was shown that PPI interact with the P450 system in the liver and reduce the platelet inhibitory effect of Clopidogrel23 Clopidogrel is activated by CYP2C19 which also metabolizes PPI4 Furthermore a recent article showed increased mortality in patients taking PPI and clopidogrel compared with patients taking clopidogrel without PPI protection5 The degree of reduction in the platelet inhibitory properties of clopidogrel might vary among the different PPI4
The use of PPI for GI protection in patients treated with dual anti-platelet therapy is not based on randomized trials but rather on expert opinion Since H2 blockers are also effective in preventing acid secretion and are not known to interact with the P450 system that affects clopidogrel the investigators hypothesized that these group of drugs will not interfere with the positive antiplatelet effects of clopidogrel and therefore will offer a good alternative treatment option
Recently it was shown that PPI interact with the P450 system in the liver and reduce the platelet inhibitory effect of Clopidogrel23 Clopidogrel is activated by CYP2C19 which also metabolizes PPI4 Furthermore a recent article showed increased mortality in patients taking PPI and clopidogrel compared with patients taking clopidogrel without PPI protection5 The degree of reduction in the platelet inhibitory properties of clopidogrel might vary among the different PPI4
The use of PPI for GI protection in patients treated with dual anti-platelet therapy is not based on randomized trials but rather on expert opinion Since H2 blockers are also effective in preventing acid secretion and are not known to interact with the P450 system that affects clopidogrel the investigators hypothesized that these group of drugs will not interfere with the positive antiplatelet effects of clopidogrel and therefore will offer a good alternative treatment option
Detailed Description:
In this study we will compare 3 different anti-acids regimens and their effect on platelet function
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