Not provided
Not provided
Not provided
Not provided
Not provided
Despite a large number of patients screened, very few met eligibility guidelines.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor- Delayed Administration | Active Comparator | Subjects receive 180 mg of ticagrelor during cardiac catheterization after diagnostic angiography and prior to stenting. OCT is performed prior to and after coronary artery stenting. |
|
| Ticagrelor- Immediate Administration | Active Comparator | Subjects receive 180 mg of ticagrelor immediately after study enrollment. OCT is performed prior to and after coronary artery stenting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor- Delayed Administration | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total thrombus burden as measured by the volume of in-stent thrombus quantified by planimetry. | The total thrombus burden measured on OCT images will be assessed. The volume of in-stent thrombus will be quantified by planimetry. | Thrombus burden will be measured at the end of the coronary artery stenting procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| PRI (platelet reactivity index) as measured bu the PLT-VASP assay. | The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays. | PRI iwill be measured at the time of OCT image acquisition. |
| P2Y12 Reaction Units as measured by the VerifyNow P2Y12 assay. |
| Measure | Description | Time Frame |
|---|---|---|
| PCI-related myocardial infarction (MI) | PCI related myocardial infarction is defined by the third Universal definition of myocardial infarction. | PCI-related MI will be assesed within 24 hours after the end of the coronary artery stenting procedure. |
Inclusion Criteria:
Patient Characteristics:
Lesion Characteristics on Diagnostic Coronary Angiography:
Exclusion Criteria:
Patient Specific Exclusion Criteria:
Lesion Specific Exclusion Criteria. These exclusion criteria apply to the target lesion to be imaged by OCT.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ik-Kyung Jang, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ticagrelor- Immediate Administration | Drug | 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. |
|
| Optical Coherence Tomography | Procedure |
|
The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays. |
| P2Y12 will be measured at the time of OCT image acquisition. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |
Not provided
Not provided