Randomized Comparison of Morning Versus Bedtime Administration of Aspirin: A Cardiovascular Circadian Chronotherapy (C3) Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32,706
- 试验地点
- 1
- 主要终点
- Composite of hospitalization for myocardial infarction, hospitalization for stroke, coronary revascularization, or cardiovascular death
研究概览
简要总结
Wide variability in the antiplatelet effects of aspirin may lead to recurrent thromboembolic events. Several pilot studies have suggested potential benefits of taking aspirin at bedtime rather than in the morning. The primary objective of this study is to examine whether aspirin administration at bedtime versus in the morning provides a superior reduction in the incidence of major adverse cardiovascular events among patients with or without established atherosclerotic cardiovascular disease, who are already taking aspirin.
详细描述
The study is a pragmatic, registry-based, open-label, randomized controlled trial combining the utilization of the Danish nationwide health registries and the official Danish electronic letter system (Digital Post/eBoks) into an innovative, decentralized trial requiring no study visits from participants. The nationwide health registries will be used for identification of potential participants and data collection, including baseline information and follow-up data, while the electronic letter system will be used for sending recruitment letters and communicating with participants. Study participants will provide electronic informed consent from home before inclusion and randomization.
The trial will include patients currently in aspirin treatment regardless of the presence or absence of established cardiovascular disease. Participants will be randomized 1:1 to either aspirin administration at bedtime or in the morning. The trial is event-driven.
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
- None
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
- •Age >=18 years
- •Current chronic treatment with aspirin (as recorded in the Danish National Prescription Registry and confirmed by the participant via questionnaire)
- •Signed informed consent
排除标准
- •There are no exclusion criteria for this trial
研究组 & 干预措施
Aspirin at bedtime
Participants randomized to aspirin administration at bedtime will be instructed to take their aspirin at approx. 8PM-12AM.
干预措施: Aspirin (Drug)
Aspirin in the morning
Participants randomized to aspirin administration in the morning will be instructed to take their aspirin upon awakening or with their breakfast (approx. 6-10AM).
干预措施: Aspirin (Drug)
结局指标
主要结局
Composite of hospitalization for myocardial infarction, hospitalization for stroke, coronary revascularization, or cardiovascular death
时间窗: Up to 3 years
次要结局
- Hospitalization for stroke(Up to 3 years)
- Coronary revascularization(Up to 3 years)
- Cardiovascular death(Up to 3 years)
- All-cause death(Up to 3 years)
- Hospitalization for myocardial infarction(Up to 3 years)
研究者
Tor Biering-Sørensen
Professor, MD, MSc, MPH, PhD
Herlev and Gentofte Hospital