NCT05932472

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32,706 (estimated)
• Sponsor: Tor Biering-Sørensen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Atherosclerosis
• Cardiovascular Diseases
• Drug Effect

Interventions

Type	Name	Description
DRUG	Aspirin	Aspirin at currently prescribed dose

Timeline

• Start date: 2024-01-15
• Primary completion: 2027-01-15
• Completion: 2027-02-15
• First posted: 2023-07-06
• Last updated: 2024-02-06

Locations

1 site across 1 country: Denmark