Phase 4 Completed N=92 Randomized Quadruple-blind Treatment

Ranitidin Versus Omeprazole in Patients Taking Clopidogrel

Coronary Artery Disease · Drug Interaction Potentiation

Source: ClinicalTrials.gov NCT01896557 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2016

Primary outcomePrimary: Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, After One Week of Randomized Treatment — 173.54; 153.61 P2Y12 Reactivity Units

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, After One Week of Randomized Treatment	173.54; 153.61	—
PRIMARY Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, Using VerifyNow Method.	17.4; 30.1	—

Eligibility 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 50 %, platelets 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01896557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.