Patients with troponin-negative acute coronary syndrome (ACS) are not routinely pre-treated with P2Y12 inhibitors and the rate of high on-treatment platelet reactivity (HPR) remains elevated after a loading dose of ticagrelor at the time of percutaneous coronary intervention (PCI). This suggests that faster platelet inhibition with crushed ticagrelor , eptifibatide , or cangrelor is needed to reduce HPR and periprocedural myocardial infarction and injury (PMI). The present study compared the effects of crushed ticagrelor vs. eptifibatide bolus + clopidogrel in troponin-negative ACS patients undergoing PCI.
Platelet activation and accumulation causes the formation of blood clots that may cause heart attack. As a standard of care, the doctor can prescribe medications such as are ticagrelor, eptifibatide, clopidogrel, to prevent the formation of blood clots. 100 patients with unstable angina, both male and female, will be randomized to either Group A- Crushed Ticagrelor or Group B- Eptifibatide bolus +Clopidogrel administrated immediately before PCI. Platelet function testing, troponin, and ECG will be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.
After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.
University of Alabama
Birmingham, Alabama, United States
Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR)
We assessed platelet aggregation at baseline and during PCI by light transmission aggregomerty. The primary efficacy measure was HPR defined as platelet aggregation \>59% at 2 h measured by the Chronlog aggregometer after stimulation with ADP 20 µM.
Time frame: 5 times (at baseline, and at 0.5, 2, 4, and 24 hours after loading dose)
Number of Participants With a Periprocedural Myocardial Infarction and Injury (PMI)
The rate of PMI will be compared in patients randomized to crushed ticagrelor vs. eptifibatide bolus +clopidogrel
Time frame: At baseline and every 8 hours post- PCI
Platelet Aggregation Levels
The rates of platelet aggregation with ADP and TRAP will be measured in patients randomized to crushed ticagrelor vs. eptifibatide bolus+clopidogrel
Time frame: At baseline and at 0.5, 2, 4, and 24 hours after loading dose
Change in Hemoglobin Levels (g/dL)
Hemoglobin levels (g/dL) will be measured at baseline and on the next day after PCI.
Time frame: At baseline and at 24 hours post-PCI
A Change in Hematocrit Levels
Hematocrit levels (%) will be measured at baseline and on the next day after PCI.
Time frame: At baseline and at 24 hours post-PCI
Heparin Dose, Unit/Kg
For the heparin dose range for the two groups would have a minimum dose of 4693 and a maximum dose of 11141 units per kilogram.The higher the number is indicative that a higher dose of heparin is needed based on kilogram weight.
Time frame: 24 hours after the PCI
Activated Clotting Time (ACT), Seconds
The Level of the highest ACT during PCI will be compared between the groups
Time frame: At the end of PCI
Number of Patients With Minor Bleeding Complications
We evaluated the number of patients with minor bleeding complications. Minor bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to \<5 g/dL.
Time frame: At 24 hours post-PCI
Number of Patients With Minor Bleeding Complications
We evaluated the number of patients with minor bleeding complications. Minor bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to \<5 g/dL.
Time frame: At 1 year post-PCI
Number of Patients With Major Bleeding Complications
We evaluated the number of patients with major bleeding complications. Major bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as type 3a, bleeding + hemoglobin drop of 3 to \<5 g/dL; type 3b, bleeding + hemoglobin drop ≥5 g/dL; and type C, intracranial hemorrhage.
Time frame: At 24 hours post-PCI
Number of Patients With Major Bleeding Complications
We evaluated the number of patients with major bleeding complications. Major bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as type 3a, bleeding + hemoglobin drop of 3 to \<5 g/dL; type 3b, bleeding + hemoglobin drop ≥5 g/dL; and type C, intracranial hemorrhage.
Time frame: At 1 year post-PCI
Number of Patients With Negative Clinical Outcomes
The rates of death, myocardial infarction, and revascularization at 1-year post-PCI.
Time frame: At 1-year post-PCI
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