Cardiovascular Disease
Conditions
Keywords
Antiplatelet, Antiplatelet therapy, platelet turnover, high platelet turnover, platelet aggregation, cardiovascular disease, coronary artery disease, diabetes mellitus
Brief summary
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.
Interventions
DRUGAspirin
steady-state run-in prior to Durlaza treatment
DRUGDurlaza™
comparison of different numbers of capsules
Sponsors
New Haven Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or non-lactating, non-pregnant female subjects * A history of Type 2 Diabetes and with history of at least one of the following: Coronary Artery Disease, Peripheral Vascular Disease, or Ischemic Stroke, along with at least 2 CVD risk factors (obese, smoker, ≥ 55 years of age, prior thrombotic event)
Exclusion criteria
* Sensitivity to aspirin or any NSAID (nonsteroidal antiinflammatory drug), * Evidence of uncontrolled or unstable cardio- or cerebrovascular disorder, * Presence of uncontrolled or chronic medical illness, GI disorder or surgery leading to impaired drug absorption, clinically significant abnormal baseline ECG, history of hepatitis, malignancy within the past five years, or HIV, history of alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in platelet aggregation | During the 26-hour hospital stays, outcomes will be measured at various timepoints |
Secondary
| Measure | 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 |
Other
| Measure | 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 |
Countries
United States
Outcome results
None listed