Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- An exploratory study with three co-primary response variables which are directly related to platelet COX-1 inhibition: arachidonic acid-induced platelet aggregation in whole blood and PRP and in the Cone-and-Plate(let) Assay (CPA)
研究概览
简要总结
The efficacy of low dose aspirin appears to be substantially lower in diabetic patients, compared to patients without diabetes. The aim of the investigators study is to test the laboratory response to different dosing of aspirin in type 2 Diabetes Mellitus. The investigators will compare the regular dose of 75mg once daily to 75 mg twice daily or to 320 mg once daily. The hypothesis of the study is that twice daily dosing of aspirin may improve the response to aspirin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 DM with micro- or macroangiopathy.
- •HbA1c 6-9 % (Mono-S method).
- •Need for, or already on-going aspirin treatment.
- •Age 50-75 years
- •Antecubital forearm veins allowing technically good sampling for platelet studies
排除标准
- •Diet controlled DM.
- •Acute ischemic stroke, acute coronary syndrome, (myocardial infarction or unstable angina pectoris), or revascularization by PCI or by-pass surgery within the last 6 months.
- •Acute or chronic kidney disease (P-cystatin C within the reference interval)
- •Acute or chronic liver disease (ALAT ≤2 times the upper reference value).
- •A history of gastric or duodenal ulcer disease.
- •Need for treatment with anticoagulants, clopidogrel, NSAID's, or thiazolidinediones.
- •Thrombocytopenia (platelet count <150 x 109/L)
- •Anticipated need for alteration of concomitant drug therapy during the course of the study.
- •Enrollment in another clinical study.
- •Contraindication(s) to aspirin treatment.
结局指标
主要结局
An exploratory study with three co-primary response variables which are directly related to platelet COX-1 inhibition: arachidonic acid-induced platelet aggregation in whole blood and PRP and in the Cone-and-Plate(let) Assay (CPA)
时间窗: 12 or 24 hours after last dose of Aspirin
次要结局
- Indirectly COX-related platelet aggregation induced by collagen or ADP, and thromboxane metabolite excretion.(12 or 24 hours after last dose of aspirin)
研究者
Paul Hjemdahl
Professor
Karolinska Institutet