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Completed

NCT Number: NCT02925923

Crushed Ticagrelor Versus Eptifibatide Bolus + Clopidogrel

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.

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Key information

Conditions

Acute Coronary Syndrome Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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<4 weeks
  • use of any thienopyridines (Clopidogrel, Prasugrel) 7 days prior to randomization
  • administration of GP IIb/IIIa inhibitors
  • bleeding diathesis or major bleeding episode within 2 weeks
  • thrombocytopenia (Platelet count < 100000)
  • incessant chest pain
  • 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
  • anemia with HCT<30%.

Treatment and study plan

Ticagrelor

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.

Other names: Brilinta

Eptifibatide

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.

Other names: Integrilin

clopidogrel

Drug

Other names: Plavix

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Number of Patients With Negative Clinical Outcomes

    Time frame: At 1-year post-PCI

    The rates of death, myocardial infarction, and revascularization at 1-year post-PCI.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 6, 2016
Registry last updated
May 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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