Assess the pharmacodynamic effect of ticagrelor vs. Clopidogrel in American Indian patients with stable coronary artery disease.
A Single Center, Randomized, Open Label, Multiple Dose, Crossover Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients With Stable Coronary Artery Disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days
Clopidogrel 600 mg loading dose followed by 75 mg Daily for 7 days ± 2 days
Regional Heart Doctors/Black Hills Cardiovascular Research
Rapid City, South Dakota, United States
Compare ticagrelor's versus clopidogrel's inhibition of the P2Y12 receptor as measured by the decrease in P2Y12 Reaction Units (PRU) using VerifyNow TM.
Time frame: At 2 hour time point after loading dose
Compare the decrease of P2Y12 Reaction Units (PRU) by VerifyNow TM from ticagrelor and clopidogrel.
Time frame: 0.5 and 8 hour time points after loading dose
Compare the decrease in P2Y l2 Reaction Units (PRU) by VerifyNow™ from ticagrelor's and clopidogrel's morning dose on Day 7
Time frame: At the 2, 8, and 24 hours after the last dose
To evaluate and compare the pharmacodynamic effects, measured by the vasodilator-stimulated phosphoprotein (VASP) assay (platelet reactivity index [PRI]), in all subjects
Time frame: Day1: pre-dose, 0.5, 2, and 8 hours post loading dose Day 7: pre-dose, 2 and 8 hours post dose Day 8: 24 hours post final dose
Assess and to compare the percentage of subjects with High on-treatment Platelet Reactivity (HPR) at all time points after randomized study treatment.
The High on-treatment Platelet Reactivity will be defined in accordance with the following platelet inhibition level cut-off. * \> 208 PRU by the VerifyNow P2Y12 assay * \> 230 PRU by the VerifyNow P2Y12 assay * \> 50% PRI by the VASP assay
Time frame: Day 1: Pre-dose, 0.5, 2 and 8 hours post loading dose Day 7: pre-dose, 2 and 8 hours post dose Day 8: 24 hours after final dose
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