Crushed Ticagrelor Versus Eptifibatide Bolus + Clopidogrel
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|ClinicalTrials.gov Identifier: NCT02925923|
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : November 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome Angina, Unstable||Drug: Ticagrelor Drug: Eptifibatide Drug: Clopidogrel||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Crushed Ticagrelor Versus Eptifibatide Bolus +Clopidogrel in Troponin-Negative ACS Patients Undergoing Coronary Intervention|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2023|
Active Comparator: Ticagrelor
crushed ticagrelor (180 mg); (n=50 patients)
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.
Other Name: Brilinta
Active Comparator: Eptifibatide bolus+clopidogrel
Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients)
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.
Other Name: Integrilin
Other Name: Plavix
- High-on treatment platelet reactivity (HPR) [ Time Frame: 5 times (at baseline, and at 0.5, 2, 4, and 24 hours after loading dose) ]The primary end-point of the study is to compare a CHANGE in HPR at 2 hours with crushed ticagrelor vs. eptifabtide bolus + clopidogrel
- Periprocedural myocardial infarction and injury (PMI) [ Time Frame: At baseline and every 8 hours post- PCI ]The rate of PMI will be compared in patients randomized to crushed ticagrelor vs. eptifibatide bolus +clopidogrel
- Platelet aggregation levels [ Time Frame: At baseline and at 0.5, 2, 4, and 24 hours after loading dose ]The rates of platelet aggregation with ADP and TRAP will be measured in patients randomized to crushed ticagrelor vs. eptifibatide bolus+clopidogrel
- Hemoglobin/hematocrit levels [ Time Frame: At baseline and at 24 hours post-PCI ]Hemoglobin and hematocrit levels will be measured at baseline and on the next day after PCI.
- Heparin dose, Unit/Kg [ Time Frame: At the end of PCI ]The total dose of heparin at the end of PCI and will be compared between the groups
- Activated clotting time (ACT), Seconds [ Time Frame: At the end of PCI ]The Level of the highest ACT during PCI will be compared between the groups
- Bleeding complications [ Time Frame: On the-next day after PCI and at 1-year post-PCI ]The rates of major and minor bleeding complications will be recorded on the next-day after PCI and at 1-year follow-up
- Clinical outcomes [ Time Frame: At 1-year post-PCI ]The rates of death, myocardial infarction, and revascularization at 1-year post-PCI.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925923
|Contact: Mehak Goel, PhDfirstname.lastname@example.org|
|United States, Alabama|
|University of Alabama||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator: Massoud Leesar, MD|
|Principal Investigator:||Massoud Leesar, MD||University of Alabama at Birmingham|