ST-elevation Myocardial Infarction Clinical Trial
Official title:
Standard (180mg) Versus Double (360mg) Loading Dose of Ticagrelor in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI): a Multi-center Randomized Parallel Pharmacodynamic Study.
This is a multi-center, prospective, randomized, single-blind, investigator initiated,
pharmacodynamic study of parallel design, performed at 3 institutions (Patras University
Hospital; Evangelismos Athens General Hospital; Gennimatas Athens General Hospital).
Patients with ST elevation myocardial infarction (symptom onset < 12 hours), undergoing
primary percutaneous coronary intervention, who are antiplatelet naïve (Group A) or present
high residual PR (defined as PRU ≥ 208) immediately before primary percutaneous coronary
intervention, will be randomized after 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 Or Ticagrelor 360mg loading dose (LD), followed by a 90mg x2 maintenance
dose (MD) starting 12±6 hours post LD Platelet reactivity assessment will be performed at
randomization (Hour 0) and at 0.5, 1, 2, 4 hours after randomization, using the VerifyNow
assay, in platelet reactivity units (PRU).
Documentation of major adverse cardiac events (death, myocardial infarction, stroke, urgent
revascularization procedure with PCI or CABG) and bleeding (according to Bleeding Academic
Research Consortium 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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