Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion

Overview

This purpose of this study is to measure platelet response to ticagrelor and eptifibatide bolus-only compared with ticagrelor and eptifibatide bolus plus 2-hour infusion administrated after cardiac catheterization in patients undergoing non-emergent percutaneous coronary intervention.

Full Title of Study: “Pharmacodynamic Effects of Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion in Patients Undergoing Percutaneous Coronary Intervention”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

Detailed Description

In this study, 70 patients with Acute Coronary Syndrome who are undergoing non-emergent percutaneous coronary intervention (PCI) will be randomized to ticagrelor loading dose and eptifibatide bolus-only versus ticagrelor loading dose and eptifibatide bolus plus 2 hour infusion administrated after cardiac catheterization, but before PCI. Platelet function testing will be performed at baseline and follow-up.

Interventions

  • Drug: Ticagrelor
    • Ticagrelor loading dose
  • Drug: Eptifibatide
    • i.v. infusion

Arms, Groups and Cohorts

  • Active Comparator: Ticagrelor and Eptifibatide bolus
    • Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)
  • Active Comparator: Ticagrelor & Eptifibatide bolus+infusion
    • Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)

Clinical Trial Outcome Measures

Primary Measures

  • Change in Percent Inhibition of Platelet Aggregation (%IPA)
    • Time Frame: Baseline and 2 hours
    • Change from baseline in %IPA at 2 hours after stimulation with 20µM ADP (µM-micromolar, ADP-Adenosine diphosphate), measured in blood by an aggregometer among patients randomized to ticagrelor and 2 boluses of eptifibatide vs. ticagrelor and 2 boluses plus infusion of eptifibatide.

Secondary Measures

  • High On-treatment Platelet Reactivity (HPR)
    • Time Frame: Comparing baseline and follow-up (2 hours)
    • Percentage of participants with HPR. HPR is defined as platelet aggregation >59% in response to 20 µM ADP.
  • Bleeding Complications
    • Time Frame: up to 24 hours
    • Number of subjects that developed gastrointestinal bleeding after Percutaneous Coronary Intervention (PCI). These subjects were categorized under Bleeding Academic Research Consortium 3b. Type 3b bleeding includes overt bleeding plus a hemoglobin drop of ≥5 g/dL (provided the hemoglobin drop is related to bleeding), cardiac tamponade, bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), and bleeding requiring intravenous vasoactive drugs.
  • Periprocedural Myocardial Infarction (PMI)
    • Time Frame: Up to 24 hours
    • Number of subjects that developed PMI. Periprocedural myocardial infarction (PMI) was defined as an increase in troponin I values >5 x 99th percentile the upper limit of normal in patients with normal baseline value on admission, or a rise of troponin I values >20% after PCI if the baseline value was elevated.

Participating in This Clinical Trial

Inclusion Criteria

For inclusion in the study subjects should fulfill the following criteria:

  • Provision of informed consent prior to any study specific procedures – Males and females aged 19 years and older – Congruent to the PLATO trial, at least two of the following three criteria have to be met: – ST-segment changes on electrocardiography, indicating ischemia; (In electrocardiography, the ST segment connects the QRS complex and the T wave and has a duration of 0.080 to 0.120 sec (80 to 120 ms). – a positive test of a biomarker, indicating myocardial necrosis; or one of several risk factors; – age >60 years – previous myocardial infarction or Coronary-Artery Bypass Grafting [CABG]; – coronary artery disease with stenosis of ≥50% in at least two vessels; – previous ischemic stroke, transient ischemic attack, carotid stenosis of at least 50%, or cerebral revascularization; – diabetes mellitus; – peripheral arterial disease; – or chronic renal dysfunction, defined as a creatinine clearance of <60 ml per minute per 1.73 m2 of body surface area). – patients with symptoms of unstable angina lasting ≥10 min and either an elevated troponin I level or newly developed ST-segment depression of 1 mm or transient ST-segment elevation of 1 mm will also be included. Exclusion Criteria:

Subjects should not enter the study if any of the following exclusion criteria are fulfilled:

  • Patients with active pathological bleeding or a history of intracranial bleeding; – patients with planned to urgent coronary artery bypass graft surgery; – severe hepatic impairment; – concomitant therapy with a strong cytochrome P-450 3A inhibitors, where 3A is s subfamily of the cytochrome P450 superfamily of genes; – surgery<4 weeks; – the use of any thienopyridine (within the previous two weeks); – upstream use of Glycoprotein (GP) IIb/IIIa inhibitors; – bleeding diathesis or major bleeding episode within 2 weeks; – a need for oral anticoagulation therapy; – thrombocytopenia; – presence of thrombus in the coronary artery; incessant chest pain or hemodynamic instability; – and patients with glomerular filtration rate (GFR)<30 mL/min or on hemodialysis. – maintenance dose of aspirin above 100mg – history of allergies to Ticagrelor – patients at increased risk of bradycardic events (e.g., patients who have sick sinus syndrome, 2nd or 3rd degree Atrioventricular block (AV block), or bradycardic related syncope and not protected with a pacemaker – women who are pregnant or breastfeeding

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alabama at Birmingham
  • Collaborator
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Principal Investigator: Massoud Leesar, MD, Professor of Medicine – University of Alabama at Birmingham
  • Overall Official(s)
    • Massoud Leesar, MD, Principal Investigator, University of Alabama at Birmingham

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