A Phase 3 interventional study of Tirofiban and Ticagrelor in Non-ST Segment Elevation Acute Coronary Syndrome, sponsored by Pusan National University Yangsan Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-12-18.
Sponsored by Pusan National University Yangsan Hospital · Phase 3, Interventional, and Treatment
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
Tirofiban : 0.4ug/kg/min for 30min followed by 0.1ug/kg/min
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
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Pusan National University Yangsan Hospital is the lead sponsor of 106 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
loading dose(180mg) followed by maintenance dose(90mg bid)
Drug: Ticagrelor
0.4ug/kg/min for 30min followed by 0.1ug/kg/min
Drug: Tirofiban
0.4ug/kg/min for 30min followed by 0.1ug/kg/min
loading dose(180mg) followed by maintenance dose(90mg bid)
Percentage 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
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
This study is status unknown, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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Pusan National University Yangsan Hospital