The purpose of this study is to compare Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients with Acute Coronary Syndromes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Asan Medical Center
Seoul, Songpa-gu, South Korea
P2Y12 reaction units(PRU)
P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay
Time frame: 8 hours and 30days after first randomized dose
Percentage inhibition of platelet aggregation
Time frame: 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment
Aggregation units(AU), Area Under the Curve(AUC)
by Multiplate analyzer
Time frame: 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment
Percentage of low-responsive patients
Low-responsive patients is defined as PRU ≥ 235 from VerifyNow P2Y12 and/or percentage of platelet inhibition \<15%
Time frame: 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment
Description of the pharmacokinetic (PK) profile for Ticagrelor and its metabolite AR-C124910XX
in terms of maximum concentration (Cmax),time to maximum concentration (tmax) and area under the concentration curve from time zero to infinity (AUC), t1/2, CL/F
Time frame: 0, 0.5, 1, 2, 4, 8, 10,24 hours after first randomized study treatment
MACE(Major adverse cardiac event)
Death, Myocardial Infarction, stent thrombosis, stroke,
Time frame: 30 days after first randomized study treatment
Adverse event
including bleeding by TIMI/PLATO criteria, dyspnea, bradycardia, syncope,
Time frame: 30 days after first randomized study treatment
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Drug tolerance
Drug tolerance is evaluated as adverse event following discontinuation of drug administration
Time frame: 30 days after first randomized study treatment