Tel Aviv Medical Center
Tel Aviv, Israel
NCT Number: NCT00950339
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 Clopidogrel2,3. 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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 4
Tel Aviv, Israel
In this study we will compare 3 different anti-acids regimens and their effect on platelet function
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each patient will undergo 3 phases of drug therapy:
A- 4 weeks of PPI treatment (omeprazole, 20mg twice daily)) B- 4 weeks of H2 blocker treatment (famotidine 40mg twice daily) C- 4 weeks of PPI treatment (pantoprazole 40mg once daily).
At the end of each phase- each patient will undergo the following evaluation:
Platelet reactivity
Other names: PPI Platelet Inhibitory
Each patient will undergo 3 phases of drug therapy:
A- 4 weeks of PPI treatment (omeprazole, 20mg twice daily)) B- 4 weeks of H2 blocker treatment (famotidine 40mg twice daily) C- 4 weeks of PPI treatment (pantoprazole 40mg once daily).
At the end of each phase- each patient will undergo the following evaluation:
Platelet reactivity
Other names: PPI Platelet Inhibitory
Each patient will undergo 3 phases of drug therapy:
A- 4 weeks of PPI treatment (omeprazole, 20mg twice daily)) B- 4 weeks of H2 blocker treatment (famotidine 40mg twice daily) C- 4 weeks of PPI treatment (pantoprazole 40mg once daily).
At the end of each phase- each patient will undergo the following evaluation:
Platelet reactivity
Other names: PPI Platelet Inhibitory
Time frame: 6 weeks
Tel-Aviv Sourasky Medical Center
Other Gov
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01231867
Acute Coronary Syndrome, Cardiovascular Diseases
London, United Kingdom
View Trial DetailsNCT07468955
Arterial Occlusive Diseases, Arteriosclerosis
Kütahya, Center, Turkey (Türkiye)
View Trial DetailsNCT05099692
Cardiac Rehabilitation, Cardiovascular Diseases
Shenyang, Liaoning, China
View Trial DetailsNCT00552591
Cardiovascular Diseases, Coronary Disease
Ottawa, Ontario, Canada
View Trial Details