Clinical trial NCT01919723: Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion
Official title: Pharmacodynamic Effects of Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion in Patients Undergoing Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Coronary Syndrome
Keywords: PCI
Ticagrelor
Eptifibatide
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2013-08-09
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 catheterization in patients undergoing non-emergent percutaneous coronary intervention.

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-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.

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

Primary outcomes:
measure: Change in Percent Inhibition of Platelet Aggregation (%IPA)
timeFrame: Baseline and 2 hours
Secondary outcomes:
measure: High On-treatment Platelet Reactivity (HPR)
timeFrame: Comparing baseline and follow-up (2 hours)
measure: Bleeding Complications
timeFrame: up to 24 hours
measure: Periprocedural Myocardial Infarction (PMI)
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Alabama at Birmingham
name: Massoud Leesar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marian MJ, Alli O, Al Solaiman F, Brott BC, Sasse M, Leesar T, Prabhu SD, Leesar MA. Ticagrelor and Eptifibatide Bolus Versus Ticagrelor and Eptifibatide Bolus With 2-Hour Infusion in High-Risk Acute Coronary Syndromes Patients Undergoing Early Percutaneous Coronary Intervention. J Am Heart Assoc. 2017 Jun 13;6(6):e005562. doi: 10.1161/JAHA.117.005562.