This is a single-center, open-label prospective randomized pharmacodynamic investigation of two anti platelet regimens in patients who are planned to undergo PCI for non-ST segment elevation acute coronary syndrome(NSTE-ACS) for 24 hours 1. Ticagrelor : loading dose(180mg) followed by maintenance dose(90mg bid) 2. Tirofiban : 0.4ug/kg/min for 30min followed by 0.1ug/kg/min * both agents will be given on top of aspirin
In combination with aspirin, P2Y12 receptor antagonist or glycoprotein IIb/IIIa inhibitor(GPI) is now a recommended drug as the standard dual antiplatelet regimen in patients with acute coronary syndrome(1). Ticagrelor is a newly developed oral P2Y12 receptor inhibitor. It shows faster, greater and more consistent platelet inhibition as compared with previous P2Y12 receptor antagonist clopidogrel(2) and it also shows better clinical outcome and similar risk for bleeding as compared with clopidogrel(3).Interestingly, pharmacodynamic data of some studies showed excellent effect of ticagrelor in terms of inhibiting platelet activation apparently as high as that of GPI(2,4). Primary hypothesis: Ticagrelor have a comparable efficacy in platelet inhibition to GPI in patients with non-ST segment elevation acute coronary syndrome. Statistical design : non-inferiority test
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
0.4ug/kg/min for 30min followed by 0.1ug/kg/min
loading dose(180mg) followed by maintenance dose(90mg bid)
Pusan National University Yangsan Hospital
Yangsan, Kyeongsangnamdo, South Korea
RECRUITINGPercentage IPA after 20µmol/l ADP at 2 hour
Blood samples anticoagulated with 0.129 mol/l sodium citrate will be collected for platelet reactivity. Platelet-rich plasma, obtained by centrifuging whole blood for 15 min at 100 g, will be stimulated with 20 µmol/l ADP and aggregation will be assessed using a light transmittance aggregometer(Chronolog, USA).
Time frame: 2 hours
Percentage IPA at 8 hours after 20µMol ADP, TRAP, Arachidonic acid, Collagen
Blood samples anticoagulated with 0.129 mol/l sodium citrate will be collected for platelet reactivity. Platelet-rich plasma, obtained by centrifuging whole blood for 15 min at 100 g, will be stimulated with 20 µmol/l ADP, TRAP, arachidonic acid and collagen and aggregation will be assessed using a light transmittance aggregometer(Chrono-log, USA).
Time frame: 8 hours
Percentage IPA at 8 hours after 20µMol ADP, TRAP, Arachidonic acid, Collagen
Blood samples with 0.129 mol/l sodium citrate will be collected for platelet reactivity. Platelet-rich plasma, obtained by centrifuging whole blood for 15 min at 100 g, will be stimulated with 20 µmol/l ADP, TRAP, arachidonic acid and collagen and aggregation will be assessed using a light transmittance aggregometer(Chrono-log, USA).
Time frame: 24 hours
periprocedural bleeding
Periprocedural bleeding will be monitored and described according to BARC and TIMI definition
Time frame: 0~24 hours
Peak cardiac enzyme level
From blood samples at 0, 2H, 8H and 24H, CK-MB and Troponin I will be measured
Time frame: 0~24 hours
Percentage IPA after TRAP, arachidonic acid, collagen at 2 hours
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Blood samples anticoagulated with 0.129 mol/l sodium citrate will be collected for platelet reactivity. Platelet-rich plasma, obtained by centrifuging whole blood for 15 min at 100 g, will be stimulated with TRAP, arachidonic acid and collagen and aggregation will be assessed using a light transmittance aggregometer(Chrono-log, USA).
Time frame: 2 hours