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Hypothesis The primary question the investigators propose to answer is whether all patients undergoing percutaneous coronary intervention (PCI) with stent deployment who receive chewed ticagrelor will demonstrate more rapid drug absorption and decreased platelet reactivity as compared to integral pill form 1 hour after drug administration.
Hypothesis The primary question the investigators propose to answer is whether all patients undergoing PCI with stent deployment who receive chewed ticagrelor will demonstrate more rapid drug absorption and decreased platelet reactivity as compared to integral pill form 1 hour after drug administration.
Secondary Hypotheses:
Major adverse cardiac and cerebrovascular event (MACCE) rate at 30 days and 1 year.
Rate of stent thrombosis and in-stent stenosis at 30 days and 1 year.
Bleeding: Defined as major, minor, or minimal bleeding based on thrombolysis in myocardial infarction (TIMI) criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Chewed ticagrelor | Experimental | Drug: Ticagrelor chewed pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline P2Y12 platelet reaction units (PRU) level is drawn and before the end of the PCI. Patients will be asked to chew, but not swallow, allowing for sublingual absorption. (Loading dose 180mg) |
|
| Active Comparator: Integral pill | Active Comparator | Drug: Ticagrelor integral pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline P2Y12 platelet reaction units (PRU) level is drawn and before the end of the PCI. Patients will swallow the loading dose followed by 25-50mL (milliliter) of water. (180mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | Chewed |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Pharmacodynamics | Platelet function was measured using the VerifyNow P2Y12 Assay (Accumetrics, San Diego, CA). This test is a turbidimetric-based optical detection system that measures ADP (Adenosine diphosphate) - induced platelet agglutination using a proprietary algorithm to report values in PRU. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE) | Measure events such as: death, repeat myocardial revascularization, cerebrovascular accident, stent thrombosis, in-stent stenosis and bleeding. | 30 days |
| Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE) |
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Inclusion Criteria:
• All patients presenting to the cardiac catheterization lab for percutaneous coronary intervention.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suhail Allaqaband, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora Health Care, St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Chewed Ticagrelor | Drug: Ticagrelor chewed pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline P2Y12 platelet reaction units (PRU) level is drawn and before the end of the percutaneous coronary intervention (PCI). Patients will be asked to chew, but not swallow, allowing for sublingual absorption. (Loading dose 180mg) Ticagrelor: Chewed |
| FG001 | Active Comparator: Integral Pill | Drug: Ticagrelor integral pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline P2Y12 platelet reaction units (PRU) level is drawn and before the end of the percutaneous coronary intervention (PCI). Patients will swallow the loading dose followed by 25-50mL (milliliters) of water. (180mg) Ticagrelor: Integral |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Chewed Ticagrelor | Drug: Ticagrelor chewed pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline PRU level is drawn and before the end of the PCI. Patients will be asked to chew, but not swallow, allowing for sublingual absorption. (Loading dose 180mg) Ticagrelor: Chewed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Concentration of Pharmacodynamics | Platelet function was measured using the VerifyNow P2Y12 Assay (Accumetrics, San Diego, CA). This test is a turbidimetric-based optical detection system that measures ADP (Adenosine diphosphate) - induced platelet agglutination using a proprietary algorithm to report values in PRU. | Posted | Median | Inter-Quartile Range | platelet reaction units | 1 hour |
|
Procedure (considered any time during procedure), post procedure (considered time after procedure and up to time of discharge), 30 day follow up, and 1 year follow up
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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 | Experimental: Chewed Ticagrelor | Drug: Ticagrelor chewed pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline PRU level is drawn and before the end of the PCI. Patients will be asked to chew, but not swallow, allowing for sublingual absorption. (Loading dose 180mg) Ticagrelor: Chewed |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death - Metastatic brain cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Death by metastatic brain cancer, determined by review of the subjects medical record |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Access site complication - Hematoma | Blood and lymphatic system disorders | Non-systematic Assessment | Access site complication - Hematoma, determined by review of subjects medical record |
Study limitations include the relatively small sample size, single-center design, and lack of pharmacokinetic confirmation of platelet reactivity.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suhail Allaqaband, MD | Aurora Health Care | 414-469-3491 | suhail.allaqaban@aah.org |
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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 | Oct 8, 2020 | Nov 2, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Ticagrelor | Drug | Integral |
|
|
Measure events such as: death, repeat myocardial revascularization, cerebrovascular accident, stent thrombosis, in-stent stenosis and bleeding. |
| 1 year |
| BG001 |
| Active Comparator: Integral Pill |
Drug: Ticagrelor integral pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline PRU level is drawn and before the end of the PCI. Patients will swallow the loading dose followed by 25-50mL of water. (180mg) Ticagrelor: Integral |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline PRU (P2Y12 platelet reaction units) | A blood sample was obtained and sent to the laboratory to register a baseline P2Y12 platelet reaction units (PRU) level prior to the randomized method of taking Ticagrelor. | Median | Inter-Quartile Range | P2Y12 platelet reaction units |
|
Drug: Ticagrelor integral pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline PRU level is drawn and before the end of the PCI. Patients will swallow the loading dose followed by 25-50mL of water. (180mg) Ticagrelor: Integral |
|
|
| Secondary | Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE) | Measure events such as: death, repeat myocardial revascularization, cerebrovascular accident, stent thrombosis, in-stent stenosis and bleeding. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE) | Measure events such as: death, repeat myocardial revascularization, cerebrovascular accident, stent thrombosis, in-stent stenosis and bleeding. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 2 |
| 46 |
| 6 |
| 46 |
| 0 |
| 46 |
| EG001 | Active Comparator: Integral Pill | Drug: Ticagrelor integral pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline PRU level is drawn and before the end of the PCI. Patients will swallow the loading dose followed by 25-50mL of water. (180mg) Ticagrelor: Integral | 1 | 48 | 3 | 48 | 5 | 48 |
|
| Death - Intracerebral hemorrhage | Cardiac disorders | Non-systematic Assessment | Death - intracerebral hemorrhage, determined by review of the subjects medical record |
|
| Death - Undetermined | General disorders | Non-systematic Assessment | Death - Undetermined, could not be determined by review of the subjects medical record |
|
| Inpatient hospitalization or prolongation of existing hospitalization | General disorders | Non-systematic Assessment | Inpatient hospitalization or prolongation of existing hospitalization, determined by review of the subjects medical record |
|
|
| Urgent revascularization | Surgical and medical procedures | Non-systematic Assessment | Urgent revascularization, determined by review of subjects medical record |
|
| Postural hypertension without syncope | Cardiac disorders | Non-systematic Assessment | Postural hypertension without syncope, determined by review of subjects medical record |
|
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| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |