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Study terminated mutually by sponsor & PI due to no enrollment
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Experimental | Subjects receive 180 mg of ticagrelor immediately prior to coronary artery stenting and have optical coherence tomography imaging after the stenting procedure. |
|
| Clopidogrel | Active Comparator | Subjects receive 600 mg of clopidogrel immediately prior to coronary artery stenting and have optical coherence tomography imaging after the stenting procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | 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. |
| 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 by the PLT-VASP assay. | The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays. | PRI will be measured at the time of OCT image acquistion (which will occur at the end of the coronary artery stenting procedure). |
| 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 defintion of myocardial infarction. | PCI-related MI will be assessed within 24 hours after the end of the coronary artery stenting procedure. |
Inclusion Criteria:
Patient Characteristics:
Males and non-pregnant females > 18 and < 79 years of age presenting with acute coronary syndrome defined as having two of the following criteria:
Patients scheduled to undergo coronary angiography with possible percutaneous coronary intervention (PCI)
Lesion Characteristics on Diagnostic Coronary Angiography
Exclusion Criteria:
General Exclusion Criteria
Lesion Specific Exclusion Criteria These exclusion criteria apply to the target lesion to be imaged by OCT.
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| 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 |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000077144 | Clopidogrel |
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
| Clopidogrel | Drug | 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. |
|
|
| Optical Coherence Tomography | Device | 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. |
|
|
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 acquistion (which will occur at the end of the coronary artery stenting procedure). |
| D003327 |
| Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |