Acute Coronary Syndrome, Coronary Artery Disease
Conditions
Keywords
Optical Coherence Tomography, ticagrelor, clopidogrel
Brief summary
Subjects with acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Subjects that are to be treated clinically with coronary artery stenting will be randomized to receive a loading dose of clopidogrel versus ticagrelor after diagnostic angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and the presence of blood clots inside the new stent will be measured and compared between the groups.
Detailed description
Subjects with acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Subjects that are to be treated clinically with coronary artery stenting will be randomized to receive a loading dose of clopidogrel versus ticagrelor after diagnostic angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and the presence of blood clots inside the new stent will be measured and compared between the groups
Interventions
DRUGTicagrelor
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
DRUGClopidogrel
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
DEVICEOptical Coherence Tomography
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
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 \> 18 and \< 79 years of age presenting with acute coronary syndrome defined as having two of the following criteria: 1. Signs and symptoms consistent with accelerated angina or prolonged angina (lasting greater than 20 minutes) either at rest or with minimal exertion 2. ECG changes indicative of new ischemia 3. Levels of cardiac biomarkers (troponin-T) above the upper limit of the normal range. 2. Patients 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
General
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 by the PLT-VASP assay. | PRI will be measured at the time of OCT image acquistion (which will occur at the end of the coronary artery stenting procedure). | 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 acquistion (which will occur at the end of the coronary artery stenting procedure). | 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 assessed within 24 hours after the end of the coronary artery stenting procedure. | PCI related myocardial infarction is defined by the third Universal defintion of myocardial infarction. |
Countries
United States
Outcome results
None listed