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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: AstraZeneca
• Treatments: Eptifibatide; Ticagrelor

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