Length of Effect of Extended Release Aspirin on Platelets in Patients With Diabetes and Heart Disease

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Drug: Aspirin
* Drug: Durlaza™


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Durlaza™, 1 capsule<br>Aspirin run-in, followed with Durlaza™, one capsule QD (quaque die), for 14 ± 4 days and an in-patient visit | Drug: Aspirin<br>* steady-state run-in prior to Durlaza treatment<br>* Other names: Bayer aspirin;Drug: Durlaza™<br>* comparison of different numbers of capsules<br>|
| Experimental: Durlaza™, 2 capsules<br>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 | Drug: Aspirin<br>* steady-state run-in prior to Durlaza treatment<br>* Other names: Bayer aspirin;Drug: Durlaza™<br>* comparison of different numbers of capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in platelet aggregation |  | During the 26-hour hospital stays, outcomes will be measured at various timepoints | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antiplatelet, Antiplatelet therapy, platelet turnover, high platelet turnover, platelet aggregation, cardiovascular disease, coronary artery disease, diabetes mellitus