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Ticagrelor therapy has been shown to reduce the rates of cardiovascular events and all-cause mortality compared to clopidogrel therapy in patients with acute coronary syndromes (ACS). The benefit of this study would be to demonstrate that ticagrelor therapy is associated with equivalent platelet inhibition irrespective of the disease status in patients undergoing PCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Experimental | As per ACC/AHA and ESC guidelines 180 mg is the recommended LD. The ticagrelor 90 mg BID dose, following the loading dose, has been selected for the clopidogrel naïve patients with stable angina, NSTEMI and STEMI patients undergoing PCI as the maintenance dose for this study since it is the FDA recommended dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ticagrelor | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inhibition of platelet aggregation | The primary end point is the pharmacodynamic (inhibition of platelet aggregation, IPA) effect of 180mg LD ticagrelor measured at 1hour post-dose by 20uM ADP-induced maximum platelet aggregation | Pre-LD dose, 0.5, 1, 2, 3, 4-6, the next day just before and 1, 2 and 4 hours after morning maintenance dose and pre-dose and 1, 2 and 4 hours after the last study MD dose (14 +/- 3 days). |
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Inclusion Criteria:
NSTEMI
For patients who had an ACS without ST-segment elevation (NTSEMI), two of the following criteria had to be met:
STEMI
For patients who had an ACS with ST-segment elevation, the following two inclusion criteria had to be met:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Gurbel, MD | Sinai Center for Thrombosis Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sinai Center for Thrombosis Research | Baltimore | Maryland | 21215 | United States |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D060050 | Angina, Stable |
| D009203 | Myocardial Infarction |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
| 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 |