Chronotherapy With Aspirin for Reduction of Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 328
- 试验地点
- 2
- 主要终点
- Incidence rate of major adverse cardiovascular events
研究概览
简要总结
This study will be a comparative effectiveness research to determine the difference in major adverse cardiovascular events between the group with aspirin after awakening and placebo before bedtime and the group with placebo after awakening and aspirin before bedtime.
详细描述
Aspirin is the cornerstone of preventive cardiovascular disease (CVD) treatment and bedtime intake of aspirin (chronotherapy) has been shown to reduce morning activity of platelets. It has been shown that platelet reactivity follows a clear circadian rhythm, with a peak of platelet reactivity during the morning (6-12 AM). Importantly, studies have shown in meta-analyses that high platelet activity is predictive of adverse cardiovascular outcomes in patients with stable CVD. Given this knowledge, it is highly likely that the morning peak of platelet reactivity contributes to the morning peak of cardiovascular events and that reduction of morning platelet activity prevents cardiovascular events during morning hours. This may be achieved by intake of aspirin at bedtime instead of on awakening. This study will be a comparative effectiveness research to determine the difference in major adverse cardiovascular events between the group with aspirin after awakening and placebo before bedtime and the group with placebo after awakening and aspirin before bedtime.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Use of low-dose aspirin (acetylsalicylic acid 80mg [brand name: acetylsalicylic acid cardio TEVA]~)
- •Patients using aspirin from an MDD ('Baxter')
- •Capacity to give informed consent (IC)
排除标准
- •Pregnancy
- •Mental or physical disability to fulfil study requirements
- •Insufficient knowledge of the Dutch language
- •Patients currently participating in another (clinical) trial or study
结局指标
主要结局
Incidence rate of major adverse cardiovascular events
时间窗: maximum of 4 years follow up
the difference in number of participants with a major adverse cardiovascular events, defined as the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, transient ischemic attack, need for repeat revascularízation by redo-CABG or repeat percutaneous intervention.
次要结局
- cost-effectiveness of the intervention(maximum of 4 years follow up)
- Comparing the incidence rate of major cardiovascular events between the two groups in the morning (6-12), evening (12-21) and night (21-6).(maximum of 4 years follow up)
- Incidence rate of side-effects between the 2 groups(maximum of 4 years follow up)
研究者
tnbonten
Assistant Professor
Leiden University Medical Center
