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临床试验/NCT04132791
NCT04132791终止不适用

Chronotherapy With Aspirin for Reduction of Cardiovascular Disease

Leiden University Medical Center2 个研究点 分布在 1 个国家目标入组 328 人开始时间: 2019年10月7日最近更新:
适应症

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

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

发起方
Leiden University Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

tnbonten

Assistant Professor

Leiden University Medical Center

研究点 (2)

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