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Ranitidin Versus Omeprazole in Patients Taking Clopidogrel

NCT01896557 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2018-07-06

Study results available
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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.

Conditions

Interventions

DRUG

omeprazole

Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated.

DRUG

Ranitidine

Influence of ranitidine on clopidogrel pharmacodynamics will be evaluated.

DRUG

Clopidogrel

Clopidogrel added to ASA therapy at the first medical visit, Open label 75 mg once a day will be given to all individuals as part of the protocol (since main outcome of interest is clopidogrel effect. Actual comparison arms are double blind ranitidine and omeprazole

Sponsors & Collaborators

  • InCor Heart Institute

    collaborator OTHER

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • José C Nicolau, Professor · Director of Acute Coronary Care Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-06-30
Completion
2013-06-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01896557 on ClinicalTrials.gov