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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
RECRUITING
Hellerup
Contact Information
Primary
Niklas Dyrby Johansen, MD
niklas.dyrby.johansen@regionh.dk
+4520204794
Backup
Manan Pareek, MD, PhD
mananpareek@dadlnet.dk
+4525536900
Time Frame
Start Date: 2024-01-15
Estimated Completion Date: 2027-02-15
Participants
Target number of participants: 32706
Treatments
Experimental: Aspirin at bedtime
Participants randomized to aspirin administration at bedtime will be instructed to take their aspirin at approx. 8PM-12AM.
Active_comparator: 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).
Related Therapeutic Areas
Sponsors
Leads: Tor Biering-Sørensen

This content was sourced from clinicaltrials.gov