This is a single-center, randomized, single-blind, investigator-initiated, pharmacological study with a parallel design. Patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention and presenting high platelet reactivity as assessed with the Verify Now P2Y12 assay-Accumetrics(Platelet Reactivity Units -PRU≥235) at 2 hours post-clopidogrel 600mg LD (Day 0), as assessed with the Verify Now P2Y12 assay, will be randomized after informed consent, in a 1:1 ratio to the following treatment groups: Group Α: Clopidogrel 150mg per day,starting from Day 1 until Day 5 (5 days after randomization) Group Β: Prasugrel 60 mg immediate loading (on Day 0) followed by 10mg/day starting from Day 1 until Day 5 (5 days after randomization). Platelet reactivity assessment will be performed 2 hours after randomization (Day 0), 24 h after randomization (Day 1) and on Day 5. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and serious adverse events (bleeding, other adverse events)will be performed until Day 5.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
35
Prasugrel 60mg immediate loading dose (Day 0)followed by 10mg/day starting from Day 1 until Day 5
Clopidogrel 150mg/d starting from Day 1
Patras University Hospital
Pátrai, Greece
Platelet reactivity
Platelet Reactivity assessed by VerifyNow P2Y12 assay 24 hours post randomization
Time frame: 24 hours post randomization (Day 1)
Platelet reactivity
Platelet Reactivity assessed by VerifyNow P2Y12 assay 2 hours post randomization
Time frame: 2 hours post randomization (Day 0)
Platelet reactivity
Platelet reactivity assessed by VerifyNow P2Y12 assay 5 days post randomization
Time frame: 5 days post randomization (Day 5)
Hyporesponsiveness rate
Hyporesponsiveness rate (PRU≥235 assessed with the VerifyNow P2Y12 assay)2 hours post randomization
Time frame: 2 hours post randomization (Day 0)
Hyporesponsiveness rate
Hyporesponsiveness rate (PRU≥235 assessed with the VerifyNow P2Y12 assay)24 hours post randomization
Time frame: 24 hours post randomization (Day 1)
Hyporesponsiveness rate
Hyporesponsiveness rate (PRU≥235 assessed with the VerifyNow P2Y12 assay)5 Days post randomization
Time frame: 5 days post randomization (Day 5)
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