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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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Assess the pharmacodynamic effect of ticagrelor vs. Clopidogrel in American Indian patients with stable coronary artery disease.
A Single Center, Randomized, Open Label, Multiple Dose, Crossover Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients With Stable Coronary Artery Disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Experimental | Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days |
|
| Clopidogrel | Active Comparator | Clopidogrel 600 mg Loading Dose followed by 75 mg Daily for 7 days ± 2 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare ticagrelor's versus clopidogrel's inhibition of the P2Y12 receptor as measured by the decrease in P2Y12 Reaction Units (PRU) using VerifyNow TM. | At 2 hour time point after loading dose |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the decrease of P2Y12 Reaction Units (PRU) by VerifyNow TM from ticagrelor and clopidogrel. | 0.5 and 8 hour time points after loading dose | |
| Compare the decrease in P2Y l2 Reaction Units (PRU) by VerifyNow™ from ticagrelor's and clopidogrel's morning dose on Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| CYP2C19 genotyping to identifying the wild-type CYP2C19 allele (*1), and characterize common alleles known to effect the metabolism of clopidogrel (*2, *3, *4,*5,*6,*7,*8 responsible for poor metabolism and *17 allele responsible for rapid metabolism). | One time-point |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James S Walder, MD | Rapid City Regional Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Heart Doctors/Black Hills Cardiovascular Research | Rapid City | South Dakota | 57701 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Clopidogrel | Drug | Clopidogrel 600 mg loading dose followed by 75 mg Daily for 7 days ± 2 days |
|
|
| At the 2, 8, and 24 hours after the last dose |
| To evaluate and compare the pharmacodynamic effects, measured by the vasodilator-stimulated phosphoprotein (VASP) assay (platelet reactivity index [PRI]), in all subjects | Day1: pre-dose, 0.5, 2, and 8 hours post loading dose Day 7: pre-dose, 2 and 8 hours post dose Day 8: 24 hours post final dose |
| Assess and to compare the percentage of subjects with High on-treatment Platelet Reactivity (HPR) at all time points after randomized study treatment. | The High on-treatment Platelet Reactivity will be defined in accordance with the following platelet inhibition level cut-off.
| Day 1: Pre-dose, 0.5, 2 and 8 hours post loading dose Day 7: pre-dose, 2 and 8 hours post dose Day 8: 24 hours after final dose |
| 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 |