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Crushed Ticagrelor Versus Eptifibatide Bolus + Clopidogrel

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ClinicalTrials.gov Identifier: NCT02925923
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Massoud Leesar, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Angina, Unstable Drug: Ticagrelor Drug: Eptifibatide Drug: Clopidogrel Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Crushed Ticagrelor Versus Eptifibatide Bolus +Clopidogrel in Troponin-Negative ACS Patients Undergoing Coronary Intervention
Study Start Date : September 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ticagrelor
crushed ticagrelor (180 mg); (n=50 patients)
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.
Other Name: Brilinta

Active Comparator: Eptifibatide bolus+clopidogrel
Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients)
Drug: 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.
Other Name: Integrilin

Drug: Clopidogrel
Other Name: Plavix




Primary Outcome Measures :
  1. High-on treatment platelet reactivity (HPR) [ Time Frame: 5 times (at baseline, and at 0.5, 2, 4, and 24 hours after loading dose) ]
    The primary end-point of the study is to compare a CHANGE in HPR at 2 hours with crushed ticagrelor vs. eptifabtide bolus + clopidogrel


Secondary Outcome Measures :
  1. 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. Hemoglobin/hematocrit levels [ Time Frame: At baseline and at 24 hours post-PCI ]
    Hemoglobin and hematocrit levels will be measured at baseline and on the next day after PCI.

  4. Heparin dose, Unit/Kg [ Time Frame: At the end of PCI ]
    The total dose of heparin at the end of PCI and will be compared between the groups

  5. 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

  6. Bleeding complications [ Time Frame: On the-next day after PCI and at 1-year post-PCI ]
    The rates of major and minor bleeding complications will be recorded on the next-day after PCI and at 1-year follow-up

  7. Clinical outcomes [ Time Frame: At 1-year post-PCI ]
    The rates of death, myocardial infarction, and revascularization at 1-year post-PCI.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925923


Contacts
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Contact: Mehak Goel, PhD 205-975-4021 mehakgoel@uabmc.edu

Locations
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United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
Principal Investigator: Massoud Leesar, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Massoud Leesar, MD University of Alabama at Birmingham

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Responsible Party: Massoud Leesar, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02925923     History of Changes
Other Study ID Numbers: F151006002
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Acute Coronary Syndrome
Angina, Unstable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Clopidogrel
Ticagrelor
Eptifibatide
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs