Coronary Heart Disease Clinical Trial
Official title:
Platelet Inhibitory Effect of Clopidogrel in Patients Treated With Omeprazole, Pantoprazole, or Famotidine
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.
In this study we will compare 3 different anti-acids regimens and their effect on platelet function ;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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