Ranitidin Versus Omeprazole in Patients Taking Clopidogrel

Coronary Artery Disease Clinical Trial

Official title: Possible Drug Interaction Between Clopidogrel and Ranitidin or Omeprazole in Patients With Stable Coronary Heart Disease: a Comparative Study

Status Completed

Clinical Trial 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.

Clinical Trial 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 and/or coronary angioplasty and/or Coronary Artery Bypass Graft (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 in the last 7 days of oral anticoagulant or any other antiplatelet drug beside ASA

• Previous utilization of PPI or ranitidine in the last 7 days before randomization

• 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]

Methodology: The study has a double-blind, double-dummy prospective design. Clopidogrel action is evaluated by platelet function tests: VerifyNow, bioimpedance aggregometry and Platelet Function Analyzer-100 (PFA-100). The patients have measurements of platelet function on three moments: before starting clopidogrel; 1 week after DAPT with clopidogrel (without loading dose) plus ASA; and after 1 week of randomization to ranitidin 150 mg bid or omeprazole 20 mg bid. ;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Drug Interaction Potentiation
• Myocardial Ischemia

• NCT number: NCT01896557
• Study type: Interventional
• Source: University of Sao Paulo General Hospital
• Status: Completed
• Phase: Phase 4
• Start date: October 2011
• Completion date: June 2013