Crushed Ticagrelor Versus Eptifibatide Bolus + Clopidogrel

The University of Alabama at Birmingham

Status and phase: Completed; Phase 2

Conditions: Acute Coronary Syndrome; Angina, Unstable

Treatments: Drug: Clopidogrel; Drug: Ticagrelor; Drug: Eptifibatide

Study type: Interventional

Funder types: Other

Identifiers

NCT02925923

F151006002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Ticagrelor

Active Comparator group

Description:

crushed ticagrelor (180 mg); (n=50 patients)

Treatment:

Drug: Ticagrelor

Eptifibatide bolus+clopidogrel

Active Comparator group

Description:

Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients)

Treatment:

Drug: Eptifibatide

Drug: Clopidogrel