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

Last updated: February 5, 2024
Sponsor: Tor Biering-Sørensen
Overall Status: Active - Recruiting

Phase

4

Condition

Atherosclerosis

Vascular Diseases

Treatment

Aspirin

Clinical Study ID

NCT05932472
ASPIRIN-C3
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >=18 years
  • Current chronic treatment with aspirin (as recorded in the Danish NationalPrescription Registry and confirmed by the participant via questionnaire)
  • Signed informed consent

Exclusion

Exclusion Criteria:

  • There are no exclusion criteria for this trial

Study Design

Total Participants: 32706
Treatment Group(s): 1
Primary Treatment: Aspirin
Phase: 4
Study Start date:
January 15, 2024
Estimated Completion Date:
February 15, 2027

Study 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.

Connect with a study center

  • Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

    Hellerup, 2900
    Denmark

    Active - Recruiting

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