Randomized Comparison of Morning Versus Bedtime Administration of Aspirin: A Cardiovascular Circadian Chronotherapy (C3) Trial

What this Trial Is About

Researchers are investigating whether taking aspirin at bedtime rather than in the morning can better reduce the risk of major heart and blood vessel problems, such as heart attacks and strokes. This study focuses on adults who are already taking aspirin, with or without diagnosed cardiovascular disease, aiming to understand if timing affects aspirin's protective effects. The trial is a phase 4, randomized controlled study using nationwide health registries and electronic communication to monitor outcomes without requiring in-person visits. Participants will be randomly assigned to take their aspirin either at bedtime, around 8 PM to midnight, or in the morning upon waking or with breakfast, between 6 and 10 AM. The study is decentralized, with recruitment and communication handled through electronic letters, and data collection via national health registries. The trial will continue until enough cardiovascular events have occurred to assess differences between the two timing groups. During the trial, participants will provide electronic consent and confirm their aspirin use via questionnaires. Researchers will track hospitalizations for heart attacks, strokes, coronary procedures, cardiovascular deaths, and overall mortality through the registries for up to three years. No study visits are needed, and participants' health outcomes will be followed remotely to evaluate the impact of aspirin timing on cardiovascular event risk.

Randomized Comparison of Morning Versus Bedtime Administration of Aspirin: A Cardiovascular Circadian Chronotherapy (C3) Trial