Platelet Inhibitory Effect of Clopidogrel in Patients Treated With Omeprazole, Pantoprazole, or Famotidine
Information source: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Heart Disease; GI Bleeding
Intervention: PPI Platelet Inhibitory (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Tel-Aviv Sourasky Medical Center Official(s) and/or principal investigator(s): Shmuel Banai, MD, Study Chair, Affiliation: Tel Aviv Medical Center, Israel
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 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.
Clinical Details
Official title: Platelet Inhibitory Effect of Clopidogrel in Patients Treated With Omeprazole, Pantoprazole, or Famotidine
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Platelet function as assessed by a CPA system
Detailed description:
In this study we will compare 3 different anti-acids regimens and their effect on platelet
function
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Subject is at least 18 years old.
2. Subject is willing to comply with pre-specified follow-up evaluation and can be
contacted by telephone.
3. Use of Clopidogrel (>=75mg) and Aspirin(>=75mg) for at least 1 month.
Exclusion Criteria:
1. Known allergy to PPI of H2 blockers
2. Known thrombocytopenia or thrombocytopathia
3. Subject is currently enrolled in another investigational study of a new drug,
biologic or device at the time of study screening. NOTE: Subjects who are
participating in the long term follow-up phase of a previously investigational and
now FDA-approved product are not excluded by this criterion.
4. Subject with symptomatic heart failure of LVEF ≤ 25%
5. Acute myocardial infarction within the past 30 days.
6. No acute inflammatory event during the past month (e. g. infection, autoimmune or
acute coronary event)
7. Concurrent medical condition with a life expectancy of less than 12 months.
8. Known severe renal failure (serum creatinine level >2. 5 mg/dl).
9. History of bleeding diathesis or coagulopathy or inability or unwillingness to
receive blood transfusions.
10. Evidence of active gastrointestinal bleeding or a history of such bleeding that is
not known to have been treated and proven to have resolved.
11. History of hepatitis (viral, ischemic or chemically-induced); clinical jaundice,
history of cirrhosis.
12. Patient treated with anticoagulant medication (Coumadin, LMWH)
Locations and Contacts
Tel Aviv Medical Center, Tel Aviv, Israel; Not yet recruiting Shmuel Banai, MD, Phone: 972-3-6973395, Email: shmuelb@tasmc.health.gov.il Yaron Arbel, MD, Phone: 972-3-6973313, Email: yaronarbel@gmail.com Yaron Arbel, MD, Principal Investigator
Additional Information
Starting date: September 2009
Last updated: July 30, 2009
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