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OpenTrials
Completed

NCT Number: NCT02370680

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

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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Key information

Conditions

Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Platelet and Thrombosis Research, LLC

Baltimore, Maryland, 21215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aspirin

Drug

steady-state run-in prior to Durlaza treatment

Other names: Bayer aspirin

Durlaza™

Drug

comparison of different numbers of capsules

Primary outcomes

  1. change in platelet aggregation

    Time frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints

Secondary outcomes

  1. Reactive Hyperemia Index

    Time frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints

  2. Safety as measured by the number and system class of adverse events reported in each treatment arm

    Time frame: participants are followed for approximately 40 to 65 days once they start study medication

Other outcomes

  1. Serum Thromboxane

    Time frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints

  2. urinary metabolites of prostacyclin and thromboxane

    Time frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints

Sponsors and collaborators

Lead sponsor

New Haven Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Acronym: DURATION

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 25, 2015
Registry last updated
Aug 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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