Ranitidin Versus Omeprazole in Patients Taking Clopidogrel

Last updated: July 5, 2018
Sponsor: University of Sao Paulo General Hospital
Overall Status: Completed

Phase

4

Condition

Hypercholesterolemia

Atherosclerosis

Chest Pain

Treatment

N/A

Clinical Study ID

NCT01896557
0136/11
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 18 years old

  • Coronary artery disease, defined as previous myocardial infarction and/or coronaryangioplasty 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

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/mm3or > 500.000/mm3; creatinin clearance < 50 ml/minute

  • Percutaneous coronary intervention (PCI) on the last 30 days before randomization (orPCI on the last year when drug-eluted stents are used); CABG surgery on the last 90days; acute coronary syndrome on the last 60 days

  • Active malignant neoplasm

  • Active peptic ulcer disease on the last 60 days or upper gastrointestinal bleeding anytime in life

  • Known allergy to the drugs clopidogrel, ranitidine or omeprazole

  • Refuse to participate in the study

Study Design

Total Participants: 92
Study Start date:
October 01, 2011
Estimated Completion Date:
June 30, 2013

Study 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.