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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

Page last updated: August 23, 2015

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