Crushed Ticagrelor Versus Eptifibatide Bolus + Clopidogrel

Acute Coronary Syndrome Clinical Trial

Official title:

The Effects of Crushed Ticagrelor Versus Eptifibatide Bolus +Clopidogrel in Troponin-Negative ACS Patients Undergoing Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925923
• Other study ID #: F151006002
• Status: Completed
• Phase: Phase 2
• Start date: November 1, 2016
• Est. completion date: December 1, 2018

Study information

• Verified date: February 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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%.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable

Intervention

Drug:
• Ticagrelor
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.
• Eptifibatide
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.
• Clopidogrel

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 times (at baseline, and at 0.5, 2, 4, and 24 hours after loading dose)
Secondary	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	At baseline and every 8 hours post- PCI
Secondary	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	At baseline and at 0.5, 2, 4, and 24 hours after loading dose
Secondary	Change in Hemoglobin Levels (g/dL)	Hemoglobin levels (g/dL) will be measured at baseline and on the next day after PCI.	At baseline and at 24 hours post-PCI
Secondary	A Change in Hematocrit Levels	Hematocrit levels (%) will be measured at baseline and on the next day after PCI.	At baseline and at 24 hours post-PCI
Secondary	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.	24 hours after the PCI
Secondary	Activated Clotting Time (ACT), Seconds	The Level of the highest ACT during PCI will be compared between the groups	At the end of PCI
Secondary	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.	At 24 hours post-PCI
Secondary	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.	At 1 year post-PCI
Secondary	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.	At 24 hours post-PCI
Secondary	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.	At 1 year post-PCI
Secondary	Number of Patients With Negative Clinical Outcomes	The rates of death, myocardial infarction, and revascularization at 1-year post-PCI.	At 1-year post-PCI