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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor and Eptifibatide bolus | Active Comparator | Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | Ticagrelor loading dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| High On-treatment Platelet Reactivity (HPR) | Percentage of participants with HPR. HPR is defined as platelet aggregation >59% in response to 20 µM ADP. | Comparing baseline and follow-up (2 hours) |
| Bleeding Complications |
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Inclusion Criteria:
For inclusion in the study subjects should fulfill the following criteria:
Exclusion Criteria:
Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
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| Name | Affiliation | Role |
|---|---|---|
| Massoud Leesar, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| University of Cincinnati |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28611098 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Ticagrelor & Eptifibatide Bolus+Infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of IPA | Baseline and 2 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mehak Goel ,PhD | University of Alabama at Birmingham | 205-975-4021 | mehakgoel@uabmc.edu |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000077542 | Eptifibatide |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Eptifibatide | Drug | i.v. infusion |
|
|
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.
| up to 24 hours |
| 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. | Up to 24 hours |
| Cincinnati |
| Ohio |
| 45267 |
| United States |
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
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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 |
|
|
| 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. | 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. | Posted | Number | percentage of participants | Comparing baseline and follow-up (2 hours) |
|
|
|
| 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. | 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. | Posted | Number | Number of subjects | up to 24 hours |
|
|
|
| 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. | 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. | Posted | Number | Number of subjects | Up to 24 hours |
|
|
|
| 10 |
| 33 |
| 0 |
| 33 |
| EG001 | 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 | 10 | 33 | 0 | 33 |
| NSTEMI | Cardiac disorders |
|
| Gastrointestinal Bleeding | Gastrointestinal disorders |
|
| Target Lesion Revascularization (TLR) | Blood and lymphatic system disorders |
|
| Periprocedural Myenecrosis | Cardiac disorders |
|
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| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D010456 | Peptides, Cyclic |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |