Acute Coronary Syndrome
Conditions
Keywords
PCI, Ticagrelor, Eptifibatide
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.
Interventions
DRUGTicagrelor
Ticagrelor loading dose
DRUGEptifibatide
i.v. infusion
Sponsors
AstraZeneca
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percent Inhibition of Platelet Aggregation (%IPA) | 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
| Measure | Time frame | Description |
|---|---|---|
| High On-treatment Platelet Reactivity (HPR) | 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 | 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) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ticagrelor and Eptifibatide Bolus Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)
Ticagrelor: Ticagrelor loading dose
Eptifibatide: i.v. infusion | 35 |
| 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)
Ticagrelor: Ticagrelor loading dose
Eptifibatide: i.v. infusion | 35 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Blood Samples Hemolyzed | 2 | 2 |
Baseline characteristics
| Characteristic | Ticagrelor and Eptifibatide Bolus | Ticagrelor & Eptifibatide Bolus+Infusion | Total |
|---|---|---|---|
| Age, Customized >=19 years | 35 participants | 35 participants | 70 participants |
| Gender Female | 17 Participants | 15 Participants | 32 Participants |
| Gender Male | 18 Participants | 20 Participants | 38 Participants |
| Region of Enrollment United States | 35 participants | 35 participants | 70 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 10 / 33 | 10 / 33 |
Outcome results
Primary
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.
Time frame: Baseline and 2 hours
Population: 2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor and Eptifibatide Bolus | Change in Percent Inhibition of Platelet Aggregation (%IPA) | 99.59 percentage of IPA | Standard Deviation 0.43 |
| Ticagrelor & Eptifibatide Bolus+Infusion | Change in Percent Inhibition of Platelet Aggregation (%IPA) | 99.88 percentage of IPA | Standard Deviation 1 |
Secondary
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.
Time frame: up to 24 hours
Population: 2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ticagrelor and Eptifibatide Bolus | Bleeding Complications | 0 Number of subjects |
| Ticagrelor & Eptifibatide Bolus+Infusion | Bleeding Complications | 1 Number of subjects |
Secondary
High On-treatment Platelet Reactivity (HPR)
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)
Population: 2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ticagrelor and Eptifibatide Bolus | High On-treatment Platelet Reactivity (HPR) | Baseline | 89 percentage of participants |
| Ticagrelor and Eptifibatide Bolus | High On-treatment Platelet Reactivity (HPR) | 2 h | 0 percentage of participants |
| Ticagrelor & Eptifibatide Bolus+Infusion | High On-treatment Platelet Reactivity (HPR) | Baseline | 79 percentage of participants |
| Ticagrelor & Eptifibatide Bolus+Infusion | High On-treatment Platelet Reactivity (HPR) | 2 h | 0 percentage of participants |
Secondary
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.
Time frame: Up to 24 hours
Population: 2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ticagrelor and Eptifibatide Bolus | Periprocedural Myocardial Infarction (PMI) | 9 Number of subjects |
| Ticagrelor & Eptifibatide Bolus+Infusion | Periprocedural Myocardial Infarction (PMI) | 7 Number of subjects |