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Assessment of platelet inhibitory response to clopidogrel when coadministered with a proton pump inhibitor - Plavix and PPI study

Phase 1
Conditions
To investigate in patients undergoing elective coronary stenting, the interaction between omeprazole, rabeprazole and ranitidine on clopodogrel inhibition of platelet activity in wild type (wt/wt) CYP2C19 extensive metabolisers”, using VerifyNow-P2Y12 assay clopidogrel assay. We will also indirectly assess the effect of clopidogrel on acid suppression by measuring gastrin hormone levels that are directly related to stomach pH.
Registration Number
EUCTR2009-011543-40-GB
Lead Sponsor
Papworth Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
72
Inclusion Criteria

Age >18
Able to consent
Elective PCI
Bleeding risk (eScore>15) and indication for PPI when on DAP

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Allergic to omeprazole, rabeprazole or ranitidine
Already on a PPI
Pregnant

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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