Pharmacodynamic Effects of Different Aspirin Dosing Regimens in Type 2 Diabetes Mellitus Patients With Coronary Artery Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Collagen Induced Aggregation
研究概览
简要总结
Since diabetic platelets are characterized by an enhanced turnover rate, it may be hypothesized that an increase in the frequency, rather than the dose, of drug administration may be a more effective strategy to inhibit platelet reactivity in diabetic patients as this may enable COX-1 blockade of newly generated platelets. However, how different dosing regimens impact the pharmacodynamic effects of aspirin selectively in diabetes mellitus has been poorly explored. Therefore, the aim of the present pilot investigation was to evaluate how increasing the frequency of aspirin administration, remaining within the daily recommended therapeutic doses, affects antiplatelet responsiveness in diabetic patients with coronary artery disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically treated (taking oral hypoglycemic medication and/or insulin) type 2 diabetes mellitus patients between 18 to 75 years with stable coronary artery disease
排除标准
- •Blood dyscrasia or bleeding diathesis
- •Oral anticoagulation therapy with a coumadin derivative
- •Recent antiplatelet treatment (< 30 days) with a glycoprotein IIb/IIIa antagonist, thienopyridine (ticlopidine, clopidogrel), cilostazol or dipyridamole Platelet count < 100 /microL
- •History of gastrointestinal bleed within last 6 months
- •History of cerebrovascular accident within last 3 months
- •History of hospitalization for an acute coronary event or coronary revascularization (percutaneous or surgical) in the past 12 months
- •Active bleeding or hemodynamic instability
- •Any active malignancy
- •Serum creatinine > 2 mg/dL
- •Baseline ALT > 2.5 times the upper limit of normal
- •Pregnant females
- •HbA1C > 10%
- •Use of nonsteroidal anti-inflammatory drugs past 10 days.
研究组 & 干预措施
Aspirin dose range
干预措施: Aspirin (Drug)
结局指标
主要结局
Collagen Induced Aggregation
时间窗: after 1 -week of treatment
Collagen induced aggregation using light transmittance aggregometry
次要结局
未报告次要终点