ST Elevation Myocardial Infarction Clinical Trial
Official title:
Pharmacodynamic Assessment of Ticagrelor vs High Dose Clopidogrel in Patients With ST Elevation Myocardial Infarction Exhibiting High Platelet Reactivity Post Fibrinolysis
This is a two-center, prospective, randomized, single-blind, investigator initiated,
pharmacodynamic study of parallel design, carried out in 2 PCI-capable cardiology centers
(Patras University Hospital and Konstantopoulio General Hospital of Athens).
Patients with ST elevation myocardial infarction, having undergone fibrinolysis in the
previous 3 to 48 hours, who present high residual PR (defined as PRU ≥208 ) on admission,
pre coronary angiography, will be randomized after written informed consent, in a 1:1 ratio
to either:
Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD) starting
12±6 hours post LD, until discharge.
Or
Clopidogrel 600mg loading dose (LD), followed by a 150mg once daily maintenance dose (MD)
starting 12±6 hours post LD, until discharge.
Platelet reactivity assessment will be performed at randomization (Hour 0) and at 2, 24
hours after randomization, as well as pre-discharge, using the VerifyNow assay, in platelet
reactivity units (PRU).
Documentation of major adverse cardiac events (death, myocardial infarction, stroke,
ischemia driven revascularization procedure with PCI or CABG) and bleeding (according to
BARC criteria) will be performed until patient's discharge.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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