Myocardial Infarction Clinical Trial
Official title:
Prasugrel in Comparison to Clopidogrel for Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)and Presenting With High Platelet Reactivity, as Assessed With a Point of Care Assay, After 600mg Clopidogrel Loading Dose
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.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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