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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- change in platelet aggregation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Durlaza™, 1 capsule
Aspirin run-in, followed with Durlaza™, one capsule QD (quaque die), for 14 ± 4 days and an in-patient visit
干预措施: Aspirin (Drug)
Durlaza™, 1 capsule
Aspirin run-in, followed with Durlaza™, one capsule QD (quaque die), for 14 ± 4 days and an in-patient visit
干预措施: Durlaza™ (Drug)
Durlaza™, 2 capsules
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
干预措施: Aspirin (Drug)
Durlaza™, 2 capsules
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
干预措施: Durlaza™ (Drug)
结局指标
主要结局
change in platelet aggregation
时间窗: During the 26-hour hospital stays, outcomes will be measured at various timepoints
次要结局
- 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)