Percutaneous Coronary Intervention
Conditions
Keywords
Ticagrelor, Stent
Brief summary
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.
Detailed description
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: 1. Major adverse cardiac and cerebrovascular event (MACCE) rate at 30 days and 1 year. 1. Death 2. Repeat myocardial infarction 3. Need for urgent revascularization 4. Cerebrovascular accident 2. Rate of stent thrombosis and in-stent stenosis at 30 days and 1 year. 3. Bleeding: Defined as major, minor, or minimal bleeding based on thrombolysis in myocardial infarction (TIMI) criteria.
Interventions
DRUGTicagrelor
Chewed
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
• All patients presenting to the cardiac catheterization lab for percutaneous coronary intervention.
Exclusion criteria
* Age \<18 years or Age \>89 years * Known coagulopathy, bleeding diathesis, or active bleeding * History of recent gastrointestinal or genitourinary bleed within 2 months * Known chronic therapy with clopidogrel, prasugrel, or ticagrelor * Major surgery within last 6 weeks * History of intracranial bleed or intracranial neoplasm * Suspected aortic dissection * Severe hemodynamic instability, cardiogenic shock * Life expectancy \<1 year * Known severe liver or renal disease * Known HIV treatment * Any use of Glycoprotein inhibitors (GP IIb-IIIa) 48-hours before the procedure or any use during the procedure * Any use of Cangrelor during or after the procedure * Hemoglobin \<10 g/dL, platelet (PLT) \<100x10\^9/L * Pregnancy * Known allergy to study medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Pharmacodynamics | 1 hour | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE) | 30 days | Measure events such as: death, repeat myocardial revascularization, cerebrovascular accident, stent thrombosis, in-stent stenosis and bleeding. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 46 |
| 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 | 48 |
| Total | 94 |
Baseline characteristics
| Characteristic | Experimental: Chewed Ticagrelor | Active Comparator: Integral Pill | Total |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 10.1 | 64.5 years STANDARD_DEVIATION 9.5 | 65.2 years STANDARD_DEVIATION 10 |
| Baseline PRU (P2Y12 platelet reaction units) | 242.5 P2Y12 platelet reaction units | 256 P2Y12 platelet reaction units | 245 P2Y12 platelet reaction units |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 46 Participants | 48 Participants | 94 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 46 participants | 48 participants | 94 participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 25 Participants |
| Sex: Female, Male Male | 33 Participants | 36 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 46 | 1 / 48 |
| other Total, other adverse events | 0 / 46 | 5 / 48 |
| serious Total, serious adverse events | 6 / 46 | 3 / 48 |
Outcome results
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.
Time frame: 1 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental: Chewed Ticagrelor | Concentration of Pharmacodynamics | 142.5 platelet reaction units |
| Active Comparator: Integral Pill | Concentration of Pharmacodynamics | 210 platelet reaction units |
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.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: Chewed Ticagrelor | Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE) | 2 Participants |
| Active Comparator: Integral Pill | Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE) | 0 Participants |
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.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: Chewed Ticagrelor | Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE) | 4 Participants |
| Active Comparator: Integral Pill | Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE) | 2 Participants |