The aim of this study is to determine both safety and effectiveness of three different loading dose regimens of clopidogrel in patients with acute myocardial infarction undergoing primary angioplasty.
This study will enroll STEMI patients, who were planned to undergo PCI, and will randomize them to three different clopidogrel loading dose regimens at first medical contact: no pre-treatment, 600 mg or 900 mg. Platelet activity after administration of clopidogrel will be evaluated by VerifyNow™ P2Y12 point-of-care system. The study is powered to demonstrate significant differences in the primary end point (the rate of TIMI Myocardial Perfusion Grade=3).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
168
Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting
Patients will receive a 600 mg clopidogrel loading dose at first medical contact
Patients will receive a 900 mg clopidogrel loading dose at first medical contact
Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy
TIMI Myocardial Perfusion Grade (TMPG)
Time frame: post-PCI
TIMI flow
Time frame: pre- and post-PCI
Corrected TIMI Frame Count (cTFC)
Time frame: post-PCI
Major bleedings
Time frame: 30 days
Major adverse cardiac events (MACEs)
Time frame: 30 days
Platelet Reactive Units (PRU) as assessed by VerifyNow™ System
Time frame: pre-PCI
TIMI 2-3 grade flow of the infarct-related artery
Time frame: pre-PCI
no reflow phenomenon
Time frame: post-PCI
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