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

January 9, 2017 updated by: Massoud Leesar, University of Alabama at Birmingham

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ticagrelor and Eptifibatide bolus
Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)
Drug: Ticagrelor
Ticagrelor loading dose
Other Names:
  • Brilinta
Drug: Eptifibatide
i.v. infusion
Other Names:
  • Integrilin
Active Comparator: Ticagrelor & Eptifibatide bolus+infusion
Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)
Drug: Ticagrelor
Ticagrelor loading dose
Other Names:
  • Brilinta
Drug: Eptifibatide
i.v. infusion
Other Names:
  • Integrilin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Percent Inhibition of Platelet Aggregation (%IPA)
Time Frame: Baseline and 2 hours
Change from baseline in %IPA at 2 hours after stimulation with 20µM ADP (µM-micromolar, ADP-Adenosine diphosphate), measured in blood by an aggregometer among patients randomized to ticagrelor and 2 boluses of eptifibatide vs. ticagrelor and 2 boluses plus infusion of eptifibatide.
Baseline and 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High On-treatment Platelet Reactivity (HPR)
Time Frame: Comparing baseline and follow-up (2 hours)
Percentage of participants with HPR. HPR is defined as platelet aggregation >59% in response to 20 µM ADP.
Comparing baseline and follow-up (2 hours)
Bleeding Complications
Time Frame: up to 24 hours
Number of subjects that developed gastrointestinal bleeding after Percutaneous Coronary Intervention (PCI). These subjects were categorized under Bleeding Academic Research Consortium 3b. Type 3b bleeding includes overt bleeding plus a hemoglobin drop of ≥5 g/dL (provided the hemoglobin drop is related to bleeding), cardiac tamponade, bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), and bleeding requiring intravenous vasoactive drugs.
up to 24 hours
Periprocedural Myocardial Infarction (PMI)
Time Frame: Up to 24 hours
Number of subjects that developed PMI. Periprocedural myocardial infarction (PMI) was defined as an increase in troponin I values >5 x 99th percentile the upper limit of normal in patients with normal baseline value on admission, or a rise of troponin I values >20% after PCI if the baseline value was elevated.
Up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Massoud Leesar, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 3, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (Estimate)

August 9, 2013

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISSBRIL0077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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