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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Ticagrelor
* Drug: Eptifibatide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ticagrelor and Eptifibatide bolus<br>Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart) | Drug: Ticagrelor<br>* Ticagrelor loading dose<br>* Other names: Brilinta;Drug: Eptifibatide<br>* i.v. infusion<br>* Other names: Integrilin;|
| Active Comparator: Ticagrelor & Eptifibatide bolus+infusion<br>Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours) | Drug: Ticagrelor<br>* Ticagrelor loading dose<br>* Other names: Brilinta;Drug: Eptifibatide<br>* i.v. infusion<br>* Other names: Integrilin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percent Inhibition of Platelet Aggregation (%IPA) | 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. | Baseline and 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High On-treatment Platelet Reactivity (HPR) | Percentage of participants with HPR. HPR is defined as platelet aggregation >59% in response to 20 µM ADP. | Comparing baseline and follow-up (2 hours) | 
| Bleeding Complications | 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. | up to 24 hours | 
| Periprocedural Myocardial Infarction (PMI) | 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. | Up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCI, Ticagrelor, Eptifibatide