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

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ticagrelor

Eptifibatide

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring PCI, Ticagrelor, Eptifibatide

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Alabama
University of Cincinnati

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Ticagrelor and Eptifibatide bolus

Ticagrelor & Eptifibatide bolus+infusion

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Percent Inhibition of Platelet Aggregation (%IPA)

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.

Secondary Outcome Measures

High On-treatment Platelet Reactivity (HPR)

Percentage of participants with HPR. HPR is defined as platelet aggregation >59% in response to 20 µM ADP.

Bleeding Complications

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.

Periprocedural Myocardial Infarction (PMI)

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.

Full Information

NCT ID

NCT01919723

First Posted

July 3, 2013

Last Updated

January 9, 2017

Sponsor

University of Alabama at Birmingham

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01919723

Brief Title

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

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

Collaborators

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

PCI, Ticagrelor, Eptifibatide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ticagrelor and Eptifibatide bolus

Arm Type

Active Comparator

Arm Description

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

Arm Title

Ticagrelor & Eptifibatide bolus+infusion

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ticagrelor

Other Intervention Name(s)

Brilinta

Intervention Description

Ticagrelor loading dose

Intervention Type

Drug

Intervention Name(s)

Eptifibatide

Other Intervention Name(s)

Integrilin

Intervention Description

i.v. infusion

Primary Outcome Measure Information:

Title

Change in Percent Inhibition of Platelet Aggregation (%IPA)

Description

Time Frame

Baseline and 2 hours

Secondary Outcome Measure Information:

Title

High On-treatment Platelet Reactivity (HPR)

Description

Percentage of participants with HPR. HPR is defined as platelet aggregation >59% in response to 20 µM ADP.

Time Frame

Comparing baseline and follow-up (2 hours)

Title

Bleeding Complications

Description

Time Frame

up to 24 hours

Title

Periprocedural Myocardial Infarction (PMI)

Description

Time Frame

Up to 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Massoud Leesar, MD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

University of Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28611098

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.

Results Reference

derived

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

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