This purpose of this study is to measure platelet response to ticagrelor and eptifibatide bolus-only compared with ticagrelor and eptifibatide bolus plus 2-hour infusion administrated after cardiac catheterization in patients undergoing non-emergent percutaneous coronary intervention.
In this study, 70 patients with Acute Coronary Syndrome who are undergoing non-emergent percutaneous coronary intervention (PCI) will be randomized to ticagrelor loading dose and eptifibatide bolus-only versus ticagrelor loading dose and eptifibatide bolus plus 2 hour infusion administrated after cardiac catheterization, but before PCI. Platelet function testing will be performed at baseline and follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Ticagrelor loading dose
i.v. infusion
University of Alabama
Birmingham, Alabama, United States
University of Cincinnati
Cincinnati, Ohio, United States
Change in Percent Inhibition of Platelet Aggregation (%IPA)
Change from baseline in %IPA at 2 hours after stimulation with 20µM ADP (µM-micromolar, ADP-Adenosine diphosphate), measured in blood by an aggregometer among patients randomized to ticagrelor and 2 boluses of eptifibatide vs. ticagrelor and 2 boluses plus infusion of eptifibatide.
Time frame: Baseline and 2 hours
High On-treatment Platelet Reactivity (HPR)
Percentage of participants with HPR. HPR is defined as platelet aggregation \>59% in response to 20 µM ADP.
Time frame: Comparing baseline and follow-up (2 hours)
Bleeding Complications
Number of subjects that developed gastrointestinal bleeding after Percutaneous Coronary Intervention (PCI). These subjects were categorized under Bleeding Academic Research Consortium 3b. Type 3b bleeding includes overt bleeding plus a hemoglobin drop of ≥5 g/dL (provided the hemoglobin drop is related to bleeding), cardiac tamponade, bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), and bleeding requiring intravenous vasoactive drugs.
Time frame: up to 24 hours
Periprocedural Myocardial Infarction (PMI)
Number of subjects that developed PMI. Periprocedural myocardial infarction (PMI) was defined as an increase in troponin I values \>5 x 99th percentile the upper limit of normal in patients with normal baseline value on admission, or a rise of troponin I values \>20% after PCI if the baseline value was elevated.
Time frame: Up to 24 hours
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