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

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ClinicalTrials.gov Identifier: NCT01919723
Recruitment Status : Completed
First Posted : August 9, 2013
Results First Posted : February 28, 2017
Last Update Posted : February 28, 2017
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Massoud Leesar, University of Alabama at Birmingham

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Ticagrelor Drug: Eptifibatide Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacodynamic Effects of Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion in Patients Undergoing Percutaneous Coronary Intervention
Study Start Date : February 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ticagrelor and Eptifibatide bolus
Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)
 Drug: Ticagrelor
Ticagrelor loading dose
Other Name: Brilinta

Drug: Eptifibatide
i.v. infusion
Other Name: Integrilin
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)
 Drug: Ticagrelor
Ticagrelor loading dose
Other Name: Brilinta

Drug: Eptifibatide
i.v. infusion
Other Name: Integrilin


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT01919723


Locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Alabama at Birmingham
AstraZeneca
Investigators
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Principal Investigator: Massoud Leesar, MD University of Alabama at Birmingham
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Massoud Leesar, MD, Professor of Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01919723    
Other Study ID Numbers: ISSBRIL0077
First Posted: August 9, 2013    Key Record Dates
Results First Posted: February 28, 2017
Last Update Posted: February 28, 2017
Last Verified: January 2017
Keywords provided by Massoud Leesar, University of Alabama at Birmingham:
PCI
Ticagrelor
Eptifibatide
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Eptifibatide
Platelet Aggregation Inhibitors
 Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs