Aspirin Statins Or Both For The Reduction Of Thrombin Generation In Diabetic People
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Thrombin generation
研究概览
简要总结
Despite formal recommendations, evidence of efficacy of aspirin in individuals with diabetes is scant and controversial. While the efficacy of aspirin versus placebo in patients with diabetes is currently under investigation in big randomized controlled trials, the putative additive effects of aspirin and statins in this population remain to be investigated. Moreover there are no data examining the pathophysiologic means by which aspirin with or without statins affects thrombosis in diabetic patients.
The aim of this trial is to evaluate the efficacy of low-dose aspirin (100 mg/daily), statins, both or neither for the reduction of thrombin generation. These preventive strategies will be evaluated on the top of the other strategies aimed at optimizing the care of diabetic patients in terms of metabolic control and control of the other cardiovascular risk factors.
详细描述
Despite the very high cardiovascular risk profile, evidence of efficacy of aspirin in individuals with diabetes is scant.
The meta-analysis on the efficacy of antiplatelet therapy involving a total of about 5,000 diabetic subjects indicates a non significant reduction in the risk of major cardiovascular events of 7%, compared with a reduction of 25% documented in secondary prevention studies.
Diabetes could represent a special case of aspirin resistance, although no specific studies have, to our knowledge, fully explored this hypothesis. The poor platelet responsiveness to aspirin has been recently proposed as a possible explanation of the failure of antiplatelet therapy to prevent cardiovascular events. The reduction in the aspirin activity in some patients is indicated by the failure in adequately suppressing thromboxane-A2 synthesis, as documented by the presence of high levels of its urinary metabolites.
The substantial lack of clear evidence is reflected by the low use of this drug in clinical practice; in fact, only 10% of diabetic patients are treated with aspirin for the prevention of cardiovascular events.
On the other hand, statins provide a similar efficacy for the prevention of major cardiovascular events in populations with and without diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus treated with insulin or orl agents
- •At least 50 years old
排除标准
- •Previous cardiovascular events
- •current or past (within last 30 days) treatment with aspirin
- •current or past (within last 180 days) treatment with statins
研究组 & 干预措施
2
Aspirin 100 mg / day
干预措施: Aspirin (Drug)
3
Atorvastatin 40 mg / day
干预措施: Atorvastatin (Drug)
4
Aspirin 100 mg / day + Atorvastatin 40 mg / day
干预措施: Aspirin + Atorvastatin (Drug)
结局指标
主要结局
Thrombin generation
时间窗: 8 weeks
次要结局
- C-reactive protein(8 weeks)