Status:
COMPLETED
Platelet Inhibitory Effect of Clopidogrel in Patients Treated With Omeprazole, Pantoprazole, or Famotidine
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Collaborating Sponsors:
Tel Aviv Medical Center
Conditions:
Coronary Heart Disease
GI Bleeding
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 percutaneou...
Detailed Description
In this study we will compare 3 different anti-acids regimens and their effect on platelet function
Eligibility Criteria
Inclusion
- Subject is at least 18 years old.
- Subject is willing to comply with pre-specified follow-up evaluation and can be contacted by telephone.
- Use of Clopidogrel (\>=75mg) and Aspirin(\>=75mg) for at least 1 month.
Exclusion
- Known allergy to PPI of H2 blockers
- Known thrombocytopenia or thrombocytopathia
- 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.
- Subject with symptomatic heart failure of LVEF ≤ 25%
- Acute myocardial infarction within the past 30 days.
- No acute inflammatory event during the past month (e.g. infection, autoimmune or acute coronary event)
- Concurrent medical condition with a life expectancy of less than 12 months.
- Known severe renal failure (serum creatinine level \>2.5 mg/dl).
- History of bleeding diathesis or coagulopathy or inability or unwillingness to receive blood transfusions.
- Evidence of active gastrointestinal bleeding or a history of such bleeding that is not known to have been treated and proven to have resolved.
- History of hepatitis (viral, ischemic or chemically-induced); clinical jaundice, history of cirrhosis.
- Patient treated with anticoagulant medication (Coumadin, LMWH)
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00950339
Start Date
August 1 2009
End Date
August 1 2011
Last Update
July 7 2016
Active Locations (1)
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1
Tel Aviv Medical Center
Tel Aviv, Israel