Ranitidin Versus Omeprazole in Patients Taking Clopidogrel
Information source: University of Sao Paulo General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: VA Drug Interactions [VA Drug Interaction]
Intervention: omeprazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Sao Paulo General Hospital Official(s) and/or principal investigator(s): José C Nicolau, Professor, Principal Investigator, Affiliation: Director of Acute Coronary Care Unit
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 Details
Official title: Possible Drug Interaction Between Clopidogrel and Ranitidin or Omeprazole in Patients With Stable Coronary Heart Disease: a Comparative Study
Study design: Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Comparing platelet function of patients on dual antiplatelet therapy with ASA + clopidogrel, between the groups ranitidin and omeprazole, using VerifyNow method.
Secondary outcome: Comparison of the primary outcome with other two methods of platelet aggregability: PFA-100 and bioimpedance aggregometry
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: October 2011
Last updated: December 2, 2014
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