Non-ST Segment Elevation Acute Coronary Syndrome Clinical Trial
Official title:
Ticagrelor vs. Tirofiban, Comparison of Anti-platelet Effects in Patients With Non-ST Elevation Acute Coronary Syndrome(TE-CLOT Trial : Ticagrelor's Effect for CLOT Prevention) ; A Single Center, Open-label Randomized Controlled Study
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
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment