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Patients with troponin-negative acute coronary syndrome (ACS) are not routinely pre-treated with P2Y12 inhibitors and the rate of high on-treatment platelet reactivity (HPR) remains elevated after a loading dose of ticagrelor at the time of percutaneous coronary intervention (PCI). This suggests that faster platelet inhibition with crushed ticagrelor , eptifibatide , or cangrelor is needed to reduce HPR and periprocedural myocardial infarction and injury (PMI). The present study compared the effects of crushed ticagrelor vs. eptifibatide bolus + clopidogrel in troponin-negative ACS patients undergoing PCI.
Platelet activation and accumulation causes the formation of blood clots that may cause heart attack. As a standard of care, the doctor can prescribe medications such as are ticagrelor, eptifibatide, clopidogrel, to prevent the formation of blood clots.
100 patients with unstable angina, both male and female, will be randomized to either Group A- Crushed Ticagrelor or Group B- Eptifibatide bolus +Clopidogrel administrated immediately before PCI. Platelet function testing, troponin, and ECG will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Active Comparator | crushed ticagrelor (180 mg); (n=50 patients) |
|
| Eptifibatide bolus+clopidogrel | Active Comparator | Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR) | We assessed platelet aggregation at baseline and during PCI by light transmission aggregomerty. The primary efficacy measure was HPR defined as platelet aggregation >59% at 2 h measured by the Chronlog aggregometer after stimulation with ADP 20 µM. | 5 times (at baseline, and at 0.5, 2, 4, and 24 hours after loading dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Periprocedural Myocardial Infarction and Injury (PMI) | The rate of PMI will be compared in patients randomized to crushed ticagrelor vs. eptifibatide bolus +clopidogrel | At baseline and every 8 hours post- PCI |
| Platelet Aggregation Levels |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31766977 | Derived | Marian MJ, Abu Daya H, Chatterjee A, Al Solaiman F, Sasse MF, Fonbah WS, Workman RW, Johnson BE, Carlson SE, Brott BC, Prabhu SD, Leesar MA. Effects of Crushed Ticagrelor Versus Eptifibatide Bolus Plus Clopidogrel in Troponin-Negative Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention: A Randomized Clinical Trial. J Am Heart Assoc. 2019 Dec 3;8(23):e012844. doi: 10.1161/JAHA.119.012844. Epub 2019 Nov 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ticagrelor | crushed ticagrelor (180 mg); (n=50 patients) Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. |
| FG001 | Eptifibatide Bolus+Clopidogrel | Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. Clopidogrel |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
2 participants of the Eptifibatide Bolus+Clopidogrel arm were unable to be analyzed due to blood samples being hemolyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ticagrelor | crushed ticagrelor (180 mg); (n=50 patients) Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. |
| 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 | Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR) | We assessed platelet aggregation at baseline and during PCI by light transmission aggregomerty. The primary efficacy measure was HPR defined as platelet aggregation >59% at 2 h measured by the Chronlog aggregometer after stimulation with ADP 20 µM. | 2 participants of the Eptifibatide Bolus+Clopidogrel arm were unable to be analyzed due to blood samples being hemolyzed | Posted | Number | count of participants | 5 times (at baseline, and at 0.5, 2, 4, and 24 hours after loading dose) |
|
4 weeks post-discharge
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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 | crushed ticagrelor (180 mg); (n=50 patients) Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Target Lesion Revascularization (TLR) | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leah Pogwizd | University of Alabama at Birmingham | (205) 996-4410 | leahpogwizd@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2019 | Jan 14, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D000789 | Angina, Unstable |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000077542 | Eptifibatide |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
|
| Eptifibatide | Drug | After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. |
|
|
| Clopidogrel | Drug |
|
|
The rates of platelet aggregation with ADP and TRAP will be measured in patients randomized to crushed ticagrelor vs. eptifibatide bolus+clopidogrel |
| At baseline and at 0.5, 2, 4, and 24 hours after loading dose |
| Change in Hemoglobin Levels (g/dL) | Hemoglobin levels (g/dL) will be measured at baseline and on the next day after PCI. | At baseline and at 24 hours post-PCI |
| A Change in Hematocrit Levels | Hematocrit levels (%) will be measured at baseline and on the next day after PCI. | At baseline and at 24 hours post-PCI |
| Heparin Dose, Unit/Kg | For the heparin dose range for the two groups would have a minimum dose of 4693 and a maximum dose of 11141 units per kilogram.The higher the number is indicative that a higher dose of heparin is needed based on kilogram weight. | 24 hours after the PCI |
| Activated Clotting Time (ACT), Seconds | The Level of the highest ACT during PCI will be compared between the groups | At the end of PCI |
| Number of Patients With Minor Bleeding Complications | We evaluated the number of patients with minor bleeding complications. Minor bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to <5 g/dL. | At 24 hours post-PCI |
| Number of Patients With Minor Bleeding Complications | We evaluated the number of patients with minor bleeding complications. Minor bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to <5 g/dL. | At 1 year post-PCI |
| Number of Patients With Major Bleeding Complications | We evaluated the number of patients with major bleeding complications. Major bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as type 3a, bleeding + hemoglobin drop of 3 to <5 g/dL; type 3b, bleeding + hemoglobin drop ≥5 g/dL; and type C, intracranial hemorrhage. | At 24 hours post-PCI |
| Number of Patients With Major Bleeding Complications | We evaluated the number of patients with major bleeding complications. Major bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as type 3a, bleeding + hemoglobin drop of 3 to <5 g/dL; type 3b, bleeding + hemoglobin drop ≥5 g/dL; and type C, intracranial hemorrhage. | At 1 year post-PCI |
| Number of Patients With Negative Clinical Outcomes | The rates of death, myocardial infarction, and revascularization at 1-year post-PCI. | At 1-year post-PCI |
| BG001 | Eptifibatide Bolus+Clopidogrel | Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. Clopidogrel |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Eptifibatide Bolus+Clopidogrel | Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. Clopidogrel |
|
|
| Secondary | Number of Participants With a Periprocedural Myocardial Infarction and Injury (PMI) | The rate of PMI will be compared in patients randomized to crushed ticagrelor vs. eptifibatide bolus +clopidogrel | 2 participants of the Eptifibatide Bolus+Clopidogrel arm were unable to be analyzed due to blood samples being hemolyzed | Posted | Count of Participants | Participants | At baseline and every 8 hours post- PCI |
|
|
|
| Secondary | Platelet Aggregation Levels | The rates of platelet aggregation with ADP and TRAP will be measured in patients randomized to crushed ticagrelor vs. eptifibatide bolus+clopidogrel | We did not have enough plasma sample to measure TRAP 10 at 4, 24 h. | Posted | Mean | Standard Deviation | μmol/L | At baseline and at 0.5, 2, 4, and 24 hours after loading dose |
|
|
|
| Secondary | Change in Hemoglobin Levels (g/dL) | Hemoglobin levels (g/dL) will be measured at baseline and on the next day after PCI. | Posted | Mean | Standard Deviation | g/dL | At baseline and at 24 hours post-PCI |
|
|
|
| Secondary | A Change in Hematocrit Levels | Hematocrit levels (%) will be measured at baseline and on the next day after PCI. | Posted | Mean | Standard Deviation | hematocrit (%) | At baseline and at 24 hours post-PCI |
|
|
|
| Secondary | Heparin Dose, Unit/Kg | For the heparin dose range for the two groups would have a minimum dose of 4693 and a maximum dose of 11141 units per kilogram.The higher the number is indicative that a higher dose of heparin is needed based on kilogram weight. | Posted | Mean | Standard Deviation | units per kilogram | 24 hours after the PCI |
|
|
|
| Secondary | Activated Clotting Time (ACT), Seconds | The Level of the highest ACT during PCI will be compared between the groups | Posted | Mean | Standard Deviation | s | At the end of PCI |
|
|
|
| Secondary | Number of Patients With Minor Bleeding Complications | We evaluated the number of patients with minor bleeding complications. Minor bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to <5 g/dL. | Posted | Count of Participants | Participants | At 24 hours post-PCI |
|
|
|
| Secondary | Number of Patients With Minor Bleeding Complications | We evaluated the number of patients with minor bleeding complications. Minor bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to <5 g/dL. | Posted | Count of Participants | Participants | At 1 year post-PCI |
|
|
|
| Secondary | Number of Patients With Major Bleeding Complications | We evaluated the number of patients with major bleeding complications. Major bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as type 3a, bleeding + hemoglobin drop of 3 to <5 g/dL; type 3b, bleeding + hemoglobin drop ≥5 g/dL; and type C, intracranial hemorrhage. | Posted | Count of Participants | Participants | At 24 hours post-PCI |
|
|
|
| Secondary | Number of Patients With Major Bleeding Complications | We evaluated the number of patients with major bleeding complications. Major bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as type 3a, bleeding + hemoglobin drop of 3 to <5 g/dL; type 3b, bleeding + hemoglobin drop ≥5 g/dL; and type C, intracranial hemorrhage. | Posted | Count of Participants | Participants | At 1 year post-PCI |
|
|
|
| Secondary | Number of Patients With Negative Clinical Outcomes | The rates of death, myocardial infarction, and revascularization at 1-year post-PCI. | Posted | Count of Participants | Participants | At 1-year post-PCI |
|
|
|
| 2 |
| 50 |
| 1 |
| 50 |
| 0 |
| 50 |
| EG001 | Eptifibatide Bolus+Clopidogrel | Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients) Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests. Clopidogrel | 0 | 50 | 0 | 50 | 0 | 50 |
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| D000787 |
| Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| 2 h (ADP 20) |
|
| 4 h (ADP 20) |
|
| 24 h (ADP 20) |
|
| Baseline (ADP 5) |
|
| 0.5 h (ADP 5) |
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| 2 h (ADP 5) |
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| 4 h (ADP 5) |
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| 24 h (ADP 5) |
|
| Baseline (TRAP 20) |
|
| 0.5 h (TRAP 20) |
|
| 2 h (TRAP 20) |
|
| 4 h (TRAP 20) |
|
| 24 h (TRAP 20) |
|
| Baseline (TRAP 10) |
|
| 0.5 h (TRAP 10) |
|
| 2 h (TRAP 10) |
|
| Revascularization |
|