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



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:19 - Any
Updated:4/21/2016
Start Date:February 2014
End Date:December 2015

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Pharmacodynamic Effects of Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion in Patients Undergoing Percutaneous Coronary Intervention

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.

In this study, 60 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.

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;

- 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;

- surgery<4 weeks;

- the use of any thienopyridine (within the previous two weeks);

- upstream use of 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 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 AV block, or bradycardic related syncope and not
protected with a pacemaker

- women who are pregnant or breastfeeding
We found this trial at
2
sites
Birmingham, Alabama 35294
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Birmingham, AL
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cincinnati, OH
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