Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Intervention: Ticagrelor; Eptifibatide
Intervention description: Ticagrelor loading dose; i.v. infusion
Intervention MeSH terms: Ticagrelor; Eptifibatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: PCI; Ticagrelor; Eptifibatide

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.
    

Eligibility 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