Kinetics of Circulating Extracellular Vesicles Over the 24-hour Dosing Interval After Low-dose Aspirin Administration in Patients at Cardiovascular Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 主要终点
- Kinetics of circulating extracellular vesicles after low-dose aspirin administration
研究概览
简要总结
Extracellular vesicles (EVs) are small vesicles deriving from all cell types during cell activation, involved in transcellular communication, and regarded as predictors of vascular damage and of cardiovascular events. The investigators will test the hypothesis that, in patients on chronic low-dose aspirin treatment for cardiovascular prevention, aspirin may affect the release of EVs within the 24 hours interval.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients on low-dose aspirin treatment for cardiovascular prevention for at least 1 month
- •arterial hypertension if well controlled with stable drug therapy
- •hypercholesterolemia if well controlled with stable drug therapy
排除标准
- •cigarette smoking insufficiency
- •clinically significant hepatic insufficiency
- •clinically significant renal insufficiency
- •clinically significant cardiac insufficiency
- •clinically significant pulmonary insufficiency
- •history of malignant neoplasms (diagnosed and treated within the past 5 years)
- •pregnancy or lactation
- •history of malabsorption
- •regular (daily) alcohol consumption
- •regular (i.e., more than 3 days per week) non steroidal anti-inflammatory drug intake
- •type 1 diabetes excluded by islet autoantibodies evaluation (anti-glutamic acid decarboxylase, islet cell cytoplasmic, and IA-2 antibodies), family history of type 1 diabetes, age lower than 40 years, lean phenotype, early requirement for insulin therapy
结局指标
主要结局
Kinetics of circulating extracellular vesicles after low-dose aspirin administration
时间窗: 1st - 12th month
In patients receiving low-dose aspirin for cardiovascular prevention, evaluate the potential effects of chronic aspirin treatment on circulating extracellular vesicles levels over the 24-hour interval
Aspirin response and circulating extracellular vesicles over the 24-hour
时间窗: 13th - 24th month
In patients receiving low-dose aspirin for cardiovascular prevention, evaluate the role of circulating extracellular vesicles as a potential determinant of interindividual variability in the aspirin response
次要结局
未报告次要终点
研究者
Francesca Santilli
Associate Professor of Internal Medicine, Department of Medicine and Aging, Head of Thrombosis and Hemostasis Unit
G. d'Annunzio University