Acute Coronary Syndrome, Coronary Artery Disease
Conditions
Keywords
Optical Coherence Tomography, Ticagrelor
Brief summary
Subjects presenting with probable acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Consented subjects will be randomized to receive ticagrelor started with a loading dose immediately after enrollment versus receiving a loading dose of ticagrelor during cardiac catheterization after diagnostic angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and the volume of thrombus within the new stent will be measured and compared between the groups.
Interventions
DRUGTicagrelor- Delayed Administration
Subjects are randomized to receive ticagrelor immediately after enrollment versus at the time of cardiac catheterization. OCT is performed prior to and after coronary artery stenting.
DRUGTicagrelor- Immediate Administration
Subjects are randomized to receive ticagrelor immediately after enrollment versus at the time of cardiac catheterization. OCT is performed prior to and after coronary artery stenting.
PROCEDUREOptical Coherence Tomography
Sponsors
AstraZeneca
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
Patient Characteristics: 1. Males and non-pregnant females \> or equal to 18 and \< or equal to 79 years of age presenting with suspected acute coronary syndrome (unstable angina or NSTEMI) 2. Patients likely to be scheduled to undergo coronary angiography with possible percutaneous coronary intervention (PCI) Lesion Characteristics on Diagnostic Coronary Angiography: 1. De novo lesions in native coronary arteries found by diagnostic coronary angiography 2. Angiographic stenosis \<100% 3. Reference vessel diameter 2.5 mm - 4.0 mm by visual estimation
Exclusion criteria
Patient Specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total thrombus burden as measured by the volume of in-stent thrombus quantified by planimetry. | Thrombus burden will be measured at the end of the coronary artery stenting procedure. | The total thrombus burden measured on OCT images will be assessed. The volume of in-stent thrombus will be quantified by planimetry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PRI (platelet reactivity index) as measured bu the PLT-VASP assay. | PRI iwill be measured at the time of OCT image acquisition. | The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays. |
| P2Y12 Reaction Units as measured by the VerifyNow P2Y12 assay. | P2Y12 will be measured at the time of OCT image acquisition. | The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays. |
Other
| Measure | Time frame | Description |
|---|---|---|
| PCI-related myocardial infarction (MI) | PCI-related MI will be assesed within 24 hours after the end of the coronary artery stenting procedure. | PCI related myocardial infarction is defined by the third Universal definition of myocardial infarction. |
Countries
United States
Outcome results
None listed