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

The University of Alabama at Birmingham

Status and phase: Completed; Phase 2

Conditions: Acute Coronary Syndrome

Treatments: Drug: Eptifibatide; Drug: Ticagrelor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01919723

ISSBRIL0077

Details and patient eligibility

About

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.

Full 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-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.

Enrollment: 70 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

Ticagrelor and Eptifibatide bolus

Active Comparator group

Description:

Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)

Treatment:

Drug: Ticagrelor

Drug: Eptifibatide

Ticagrelor & Eptifibatide bolus+infusion

Active Comparator group

Description:

Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)

Treatment:

Drug: Ticagrelor

Drug: Eptifibatide