Clinical trial NCT02925923: Crushed Ticagrelor Versus Eptifibatide Bolus + Clopidogrel
Official title: The Effects of Crushed Ticagrelor Versus Eptifibatide Bolus +Clopidogrel in Troponin-Negative ACS Patients Undergoing Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Coronary Syndrome
Angina, Unstable
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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%.

Primary outcomes:
measure: Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR)
timeFrame: 5 times (at baseline, and at 0.5, 2, 4, and 24 hours after loading dose)
Secondary outcomes:
measure: Number of Participants With a Periprocedural Myocardial Infarction and Injury (PMI)
timeFrame: At baseline and every 8 hours post- PCI
measure: Platelet Aggregation Levels
timeFrame: At baseline and at 0.5, 2, 4, and 24 hours after loading dose
measure: Change in Hemoglobin Levels (g/dL)
timeFrame: At baseline and at 24 hours post-PCI
measure: A Change in Hematocrit Levels
timeFrame: At baseline and at 24 hours post-PCI
measure: Heparin Dose, Unit/Kg
timeFrame: 24 hours after the PCI
measure: Activated Clotting Time (ACT), Seconds
timeFrame: At the end of PCI
measure: Number of Patients With Minor Bleeding Complications
timeFrame: At 24 hours post-PCI
measure: Number of Patients With Minor Bleeding Complications
timeFrame: At 1 year post-PCI
measure: Number of Patients With Major Bleeding Complications
timeFrame: At 24 hours post-PCI
measure: Number of Patients With Major Bleeding Complications
timeFrame: At 1 year post-PCI
measure: Number of Patients With Negative Clinical Outcomes
timeFrame: At 1-year post-PCI
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Massoud Leesar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marian MJ, Abu Daya H, Chatterjee A, Al Solaiman F, Sasse MF, Fonbah WS, Workman RW, Johnson BE, Carlson SE, Brott BC, Prabhu SD, Leesar MA. Effects of Crushed Ticagrelor Versus Eptifibatide Bolus Plus Clopidogrel in Troponin-Negative Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention: A Randomized Clinical Trial. J Am Heart Assoc. 2019 Dec 3;8(23):e012844. doi: 10.1161/JAHA.119.012844. Epub 2019 Nov 26.