Phase 2
N=100
Crushed Ticagrelor Versus Eptifibatide Bolus + Clopidogrel
Acute Coronary Syndrome · Angina, Unstable
Bottom Line
View on ClinicalTrials.gov: NCT02925923 ↗Enrolled (actual)
100
Serious AEs
1.0%
Results posted
May 2020
Primary outcome: Primary: Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR) — 37; 33; 24; 0 count of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ticagrelor (Drug); Eptifibatide (Drug); Clopidogrel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR) |
37; 33; 24; 0; 6; 0 | — |
| SECONDARY Number of Participants With a Periprocedural Myocardial Infarction and Injury (PMI) |
24; 14 | — |
| SECONDARY Platelet Aggregation Levels |
65; 62; 53; 1.3; 35; .34 | — |
| SECONDARY Change in Hemoglobin Levels (g/dL) |
13.52; 13.34; 12.73; 12.71 | — |
| SECONDARY A Change in Hematocrit Levels |
40.11; 40.02; 37.68; 37.5 | — |
| SECONDARY Heparin Dose, Unit/Kg |
8854; 6021 | — |
| SECONDARY Activated Clotting Time (ACT), Seconds |
332; 278 | — |
| SECONDARY Number of Patients With Minor Bleeding Complications |
0; 0 | — |
| SECONDARY Number of Patients With Minor Bleeding Complications |
0; 0 | — |
| SECONDARY Number of Patients With Major Bleeding Complications |
0; 0 | — |
| SECONDARY Number of Patients With Major Bleeding Complications |
0; 0 | — |
| SECONDARY Number of Patients With Negative Clinical Outcomes |
2; 0; 0; 0; 1; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients with unstable angina/troponin negative ACS.
Exclusion Criteria
- need for oral anticoagulation therapy (Warfarin, Dabigatran, Rivaroxaban, Apixaban, Edoxaban)
- 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)
- surgery 0.034 ng/ml); renal failure with a serum creatinine >2.0 mg/dL
- anemia with HCT<30%.
Data sourced from ClinicalTrials.gov (NCT02925923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.