Ranitidin Versus Omeprazole in Patients Taking Clopidogrel

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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 on dual antiplatelet therapy(DAPT). Because of this, ranitidin has been proposed as an alternative drug to PPI´s for prophylaxis of gastrointestinal bleeding in patients who need DAPT. The study´s aim is to test the hypothesis that ranitidin doesn´t have any influence on clopidogrel pharmacodynamic.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital
• Collaborator: InCor Heart Institute
• Treatments: Clopidogrel; Omeprazole; Purinergic P2Y Receptor Antagonists; Ranitidine; Ranitidine bismuth citrate; Ticlopidine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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