CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 92 enrolled
Drug / intervention
omeprazole +2 moredrug
Likely dose
Clopidogrel 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01896557
NCT01896557Phase 4Completed
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Possible Drug Interaction Between Clopidogrel and Ranitidin or Omeprazole in Patients With Stable Coronary Heart Disease: a Comparative Study

University of Sao Paulo General Hospital·interventional·Posted Jul 11, 2013·Updated Jul 6, 2018

In Brief

A Phase 4 clinical trial evaluating omeprazole, Ranitidine, and 1 other intervention for Coronary Artery Disease and Drug Interaction Potentiation. Completed, enrolled 92 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Drug Interaction Potentiation
Countries--
CollaboratorsInCor Heart Institute

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 11, 2013
Enrollment StartOct 1, 2011
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.0 years ago

Interventions

omeprazoledrug

Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated.

Ranitidinedrug

Influence of ranitidine on clopidogrel pharmacodynamics will be evaluated.

Clopidogreldrug

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