Status:
UNKNOWN
Effect of Proton Pump Inhibitor on Residual Platelet Reactivity After Clopidogrel in Homogenous Genetic Strata
Lead Sponsor:
Università degli Studi di Ferrara
Conditions:
Coronary Stenting
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study aims to prospectively assess whether there is an interaction between genetic status in terms of 2C19 activity and residual platelet reactivity after clopidogrel intake in patients who under...
Detailed Description
In managing patients who undergo percutaneous coronary intervention (PCI), rapid and predictable platelet inhibition for all patients is an important therapeutic goal. Determining the optimal dose of ...
Eligibility Criteria
Inclusion
- All comer patients undergoing PCI will be recruited on a consecutive basis.
- • Patients will undergo screening before or soon after PCI depending on their clinical presentation as follows:
- STEMI patients will receive upstream treatment with 600 mg clopidogrel before PCI and will undergo screening for 2C19 status within 24 hours after treatment. Randomization will occur immediately thereafter.
- Stable and NSTEACS patients will be treated upstream with 600 mg clopidogrel and will undergo screening either before PCI or soon after (within 6 hours) revascularisation. In both scenarios randomization will occur immediately after the genotype status is known without any additional delay.
Exclusion
- Patients who can not give informed consent or have a life expectancy of \< 1 year
- Ongoing bleeding or bleeding diathesis or increase bleeding risk or history of bleeding in the last 2 months
- Age \> 90
- Previous stroke or TIA or any intracranial pathology
- Major surgery or trauma within the previous six weeks
- Platelet count \< 100.000 per cubic mm or HCT ,33% or Hb \< 11 gm/dL
- Subjects with an allergy or intolerance to prasugrel or to clopidogrel
- Planned elective cardiac or non-cardiac surgery within 1 month.
- Current or planned therapy with coumadin anticoagulation.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
522 Patients enrolled
Trial Details
Trial ID
NCT01512953
Start Date
January 1 2011
End Date
August 1 2013
Last Update
January 20 2012
Active Locations (1)
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1
University Hospital of Ferrara
Ferrara, ER, Italy, 44100