Comparing morning versus bedtime aspirin for cardiovascular health
Randomized Comparison of Morning Versus Bedtime Administration of Aspirin: A Cardiovascular Circadian Chronotherapy (C3) Trial
This study is testing if taking aspirin at bedtime works better than taking it in the morning for people who are already using aspirin to protect their heart health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 32706 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev and Gentofte Hospital Academic / other |
| Locations | 1 site (Hellerup) |
| Trial ID | NCT05932472 on ClinicalTrials.gov |
What this trial studies
This trial investigates whether taking aspirin at bedtime is more effective than taking it in the morning for reducing major adverse cardiovascular events in patients already on aspirin therapy. It utilizes a pragmatic, registry-based, open-label, randomized controlled design, leveraging Denmark's nationwide health registries for participant identification and data collection. Participants will provide electronic informed consent and will be randomized to either morning or bedtime aspirin administration without the need for in-person visits.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are currently on chronic aspirin treatment.
Not a fit: Patients who are not currently taking aspirin or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular outcomes for patients through optimized aspirin administration timing.
How similar studies have performed: Previous pilot studies have suggested potential benefits of bedtime aspirin administration, indicating a promising avenue for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * There are no exclusion criteria for this trial
Where this trial is running
Hellerup
- Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte — Hellerup, Denmark (Recruiting)
Study contacts
- Principal investigator: Manan Pareek, MD, PhD — Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
- Study coordinator: Niklas Dyrby Johansen, MD
- Email: niklas.dyrby.johansen@regionh.dk
- Phone: +4520204794
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.