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

Acute Coronary Syndrome Clinical Trial

Official title:

Pharmacodynamic Effects of Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion in Patients Undergoing Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01919723
• Other study ID #: ISSBRIL0077
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2013
• Last updated: March 30, 2016
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

In this study, 60 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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;

• 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;

• surgery<4 weeks;

• the use of any thienopyridine (within the previous two weeks);

• upstream use of 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 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 AV block, or bradycardic related syncope and not protected with a pacemaker

• women who are pregnant or breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Drug:
• ticagrelor
ticagrelor loading dose
• Eptifibatide
i.v. infusion

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of bleeding complications	Comparison of bleeding complications in patients randomized to ticagrelor and 2 boluses of eptifibatide with ticagrelor and 2 boluses plus 2-h infusion of eptifibatide.	Comparing baseline and follow-up (18 hours)	Yes
Primary	Change in percent inhibition of platelet activity	Change from baseline in percent inhibition of platelet activity (%IPA) at 6 hours measured in the blood by an aggregomter among patients randomized to ticagrelor and 2 boluses of eptifibatide vs. ticagrelor and 2 boluses plus infusion of eptifibatide.	Comparing baseline with follow-up (6 hours)	No
Secondary	Correlations between platelet activity inhibition	Correlations between the percent inhibition of platelet activity (% IPA) in the blood measured by an aggregomter after exposure of blood to agonists such as adenosine diphosphate versus thrombin receptor agonist peptide.	Comparing baseline and follow-up (6 hours)	No