Status:
COMPLETED
Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
AstraZeneca
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
19+ years
Phase:
PHASE2
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 ca...
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-on...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01919723
Start Date
February 1 2014
End Date
December 1 2015
Last Update
February 28 2017
Active Locations (2)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
University of Cincinnati
Cincinnati, Ohio, United States, 45267