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 |
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.
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.
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
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