Length of Effect of Extended Release Aspirin on Platelets in Patients With Diabetes and Heart Disease
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2015 |
| End Date: | July 2015 |
Durability of Antiplatelet Effect of a Novel Extended-Release Formulation of Acetylsalicylic Acid, Durlaza in CVD (Cardiovascular Disease) Patients at Risk of High Platelet Turnover
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.
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.
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.
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