* The purpose of this study is to determine the level of inhibition of platelet activation of an approved thienopyridine(clopidogrel or prasugrel) and aspirin regimen in the setting of drug eluting coronary stent implantation. * In subjects with high residual levels of platelet reactivity after receiving either a maintenance or loading dose of either clopidogrel or prasugrel, a cross over of thienopyridine treatment to the alternate medication will occur. * The study tests the hypothesis that adequate platelet inhibition will occur in subjects who have high levels of platelet reactivity and are subsequently switched from clopidogrel to prasugrel(loading or maintenance dose) without increased episodes of bleeding or MACE events at discharge and 30 days post Percutaneous Coronary Intervention (PCI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
Subjects who are thienopyridine naive will be randomized 1:1 to either clopidogrel 600 mg or prasugrel 60 mg loading dose at the time of PCI. A Verify Now P2Y12 platelet assay will measure platelet reactivity. Cross over to loading dose and maintenance dose of alternate medication will occur based on level of platelet reactivity.
Verify Now P2Y12 platelet assay will measure platelet reactivity. Cross over to a loading dose and maintenance dose of alternate medication will occur based on level of platelet reactivity.
St. Francis Hospital
Roslyn, New York, United States
RECRUITINGChange in platelet reactivity after switching medication regimen of two thienopyridines- clopidogrel and prasugrel
Platelet reactivity will be measured using the Accumetrics Verify Now P2Y12 platelet assay
Time frame: 4 hours post medicaton administration
Occurrence of all bleeding events for subjects enrolled into the trial
All bleeding events will be observed, reported and adjudicated by the DSMB
Time frame: 24 hours post PCI or at time of discharge and 30 days post PCI
Occurrence of all MACE events for subjects enrolled into the trial
All bleeding events will be observed, reported and adjudicated by the DSMB
Time frame: 24 hours post PCI or at time of discharge and 30 days post PCI
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