Current partner codePEPTIDESDE
NCT01919723·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

70

Locations

2

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Ticagrelor

Ticagrelor loading dose

DRUG

Eptifibatide

i.v. infusion

Timeline

From registration to results.

  1. First posted

    Aug 9, 2013

  2. Study start

    Feb 2014

  3. Primary completion

    Dec 2015

  4. Study completion

    Dec 2015

  5. Results posted

    Feb 28, 2017

  6. Registry updated

    Feb 28, 2017

Outcomes

What the study measures.

Primary outcomes

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.

Secondary outcomes

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.

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.

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.

Eligibility

Who can take part.

Minimum age
19 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

2 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

University of Alabama

Birmingham, Alabama, United States

University of Cincinnati

Cincinnati, Ohio, United States

Related trials

More studies on Eptifibatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.