Status
Completed
Phase
Phase 2
Enrollment
100
Locations
1
Results
Posted
Publications
1
Study summary
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.
Interventions
DRUG
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.
DRUG
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.
DRUG
Timeline
First posted
Oct 6, 2016
Study start
Nov 1, 2016
Primary completion
Jan 30, 2018
Study completion
Dec 1, 2018
Results posted
May 4, 2020
Registry updated
May 4, 2020
Outcomes
Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR)
Time frame · 5 times (at baseline, and at 0.5, 2, 4, and 24 hours after loading dose)
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.
Number of Participants With a 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
Change in Hemoglobin Levels (g/dL)
Time frame · At baseline and at 24 hours post-PCI
Hemoglobin levels (g/dL) will be measured at baseline and on the next day after PCI.
A Change in Hematocrit Levels
Time frame · At baseline and at 24 hours post-PCI
Hematocrit levels (%) will be measured at baseline and on the next day after PCI.
Heparin Dose, Unit/Kg
Time frame · 24 hours after the PCI
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.
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
Number of Patients With Minor Bleeding Complications
Time frame · At 24 hours post-PCI
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.
Number of Patients With Minor Bleeding Complications
Time frame · At 1 year post-PCI
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.
Number of Patients With Major Bleeding Complications
Time frame · At 24 hours post-PCI
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.
Number of Patients With Major Bleeding Complications
Time frame · At 1 year post-PCI
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.
Eligibility
Inclusion Criteria: * Patients with unstable angina/troponin negative ACS. Exclusion Criteria: 1. need for oral anticoagulation therapy (Warfarin, Dabigatran, Rivaroxaban, Apixaban, Edoxaban) 2. increased risk of bradycardia, and the associated therapy with a strong cytochrome P-450 inhibitors (anti-retroviral agents, antifungal agents and some antibiotics eg. Indinavir, Nelfinavir, Lopinavir, Ritonavir, Itraconazole, Ketoconazole, Voriconazole, Clarithromycin, Telithormycin) 3. surgery\<4 weeks 4. use of any thienopyridines (Clopidogrel, Prasugrel) 7 days prior to randomization 5. administration of GP IIb/IIIa inhibitors 6. bleeding diathesis or major bleeding episode within 2 weeks 7. thrombocytopenia (Platelet count \< 100000) 8. incessant chest pain 9. hemodynamic instability (Mean arterial pressure \< 65 mm Hg; need for vasopressor or inotropic agents; need for mechanical circulatory support for coronary intervention), NSTEMI as evidenced by elevation of troponin levels (Troponin \> 0.034 ng/ml); renal failure with a serum creatinine \>2.0 mg/dL 10. anemia with HCT\<30%.
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
University of Alabama
Birmingham, Alabama, United States
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