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

NCT01919723 | Completed Phase 2 Results

• 1 other identifier: ISSBRIL0077
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Coronary Syndrome

Keywords

PCI; Ticagrelor; Eptifibatide

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 2 hours

Secondary Outcomes (3)

• High On-treatment Platelet Reactivity (HPR)

  Comparing baseline and follow-up (2 hours)

• Bleeding Complications

  up to 24 hours

• Periprocedural Myocardial Infarction (PMI)

  Up to 24 hours

Study Arms (2)

Ticagrelor and Eptifibatide bolus

ACTIVE COMPARATOR

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

Drug: Ticagrelor; Drug: Eptifibatide

Ticagrelor & Eptifibatide bolus+infusion

ACTIVE COMPARATOR

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

Drug: Ticagrelor; Drug: Eptifibatide

Interventions

Ticagrelor DRUG

Ticagrelor loading dose

Also known as: Brilinta

Ticagrelor & Eptifibatide bolus+infusion; Ticagrelor and Eptifibatide bolus

Eptifibatide DRUG

i.v. infusion

Also known as: Integrilin

Ticagrelor & Eptifibatide bolus+infusion; Ticagrelor and Eptifibatide bolus

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• AstraZeneca: collaborator

Study Sites (2)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Related Publications (1)

• 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.

  PMID: 28611098 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Ticagrelor; Eptifibatide

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Mehak Goel ,PhD
• Organization: University of Alabama at Birmingham

mehakgoel@uabmc.edu

205-975-4021

Study Officials

• Massoud Leesar, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor of Medicine

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: August 9, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 28, 2017
• Results First Posted: February 28, 2017

Record last verified: 2017-01

Locations

US (2)