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This study is being conducted to evaluate the safety and the length of effect on platelet build-up in the arteries of Durlaza™ as compared to immediate-release Bayer® aspirin 81 mg or subject's current aspirin 81 mg of choice in patients who have Type 2 diabetes mellitus and cardiovascular disease or multiple risk factors of developing cardiovascular disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Durlaza™, 1 capsule | Experimental | Aspirin run-in, followed with Durlaza™, one capsule QD (quaque die), for 14 ± 4 days and an in-patient visit |
|
| Durlaza™, 2 capsules | Experimental | in a rollover with 10 subjects from the first arm, an aspirin run-in, followed by Durlaza™, two capsules QD, for 14 ± 4 days and an in-patient visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | steady-state run-in prior to Durlaza treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in platelet aggregation | During the 26-hour hospital stays, outcomes will be measured at various timepoints |
| Measure | Description | Time Frame |
|---|---|---|
| Reactive Hyperemia Index | During the 26-hour hospital stays, outcomes will be measured at various timepoints | |
| Safety as measured by the number and system class of adverse events reported in each treatment arm | participants are followed for approximately 40 to 65 days once they start study medication |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Thromboxane | During the 26-hour hospital stays, outcomes will be measured at various timepoints | |
| urinary metabolites of prostacyclin and thromboxane | During the 26-hour hospital stays, outcomes will be measured at various timepoints |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Gurbel, MD | Platelet Thrombosis Research, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Platelet and Thrombosis Research, LLC | Baltimore | Maryland | 21215 | United States |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003324 | Coronary Artery Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Durlaza™ | Drug | comparison of different numbers of capsules |
|
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |