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

NCT ID: NCT01919723

Last Updated: 2017-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-12-31

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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ticagrelor and Eptifibatide bolus

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

Group Type: ACTIVE_COMPARATOR

Ticagrelor

Intervention Type: DRUG

Ticagrelor loading dose

Eptifibatide

Intervention Type: DRUG

i.v. infusion

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)

Group Type: ACTIVE_COMPARATOR

Ticagrelor

Intervention Type: DRUG

Ticagrelor loading dose

Eptifibatide

Intervention Type: DRUG

i.v. infusion

Interventions

Ticagrelor

Ticagrelor loading dose

Intervention Type: DRUG

Eptifibatide

i.v. infusion

Intervention Type: DRUG

Other Intervention Names

Brilinta; Integrilin

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

• 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Massoud Leesar

MD, Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Massoud Leesar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama

Birmingham, Alabama, United States

University of Cincinnati

Cincinnati, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28611098 (View on PubMed)

Other Identifiers

ISSBRIL0077

Identifier Type: -

Identifier Source: org_study_id