Status:
COMPLETED
Ranitidin Versus Omeprazole in Patients Taking Clopidogrel
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborating Sponsors:
InCor Heart Institute
Conditions:
Coronary Artery Disease
Drug Interaction Potentiation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Previous reports have shown a possible drug interaction between clopidogrel and proton pump inhibitors (PPI´s), which could result in increased number of adverse cardiovascular events among patients o...
Detailed Description
Study population: 100 patients with Stable Coronary Artery Disease from Heart Institute Inclusion Criteria: * Age \> 18 years old * Coronary artery disease, defined as previous myocardial infarction...
Eligibility Criteria
Inclusion
- Age \> 18 years old
- Coronary artery disease, defined as previous myocardial infarction and/or coronary angioplasty and/or CABG surgery and/or coronariography showing obstruction of at least 50 % in one of major epicardial vessels
- Treatment with Acetylsalicylic Acid (ASA) 100 mg/day
Exclusion
- Use on the last 7 days of any other antiplatelet drug beside ASA or oral anticoagulant
- Previous utilization of PPI or ranitidine in the last 7 days before randomization
- Any active bleeding
- Pregnancy or woman of childbearing age without contraceptive method
- Hemoglobin \< 10 g/dL or hematocrit \< 30 %, hematocrit \> 50 %, platelets \< 100.000/mm3 or \> 500.000/mm3; creatinin clearance \< 50 ml/minute
- Percutaneous coronary intervention (PCI) on the last 30 days before randomization (or PCI on the last year when drug-eluted stents are used); CABG surgery on the last 90 days; acute coronary syndrome on the last 60 days
- Active malignant neoplasm
- Active peptic ulcer disease on the last 60 days or upper gastrointestinal bleeding any time in life
- Known allergy to the drugs clopidogrel, ranitidine or omeprazole
- Refuse to participate in the study
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01896557
Start Date
October 1 2011
End Date
June 1 2013
Last Update
July 6 2018
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