NCT05932472 Randomized Comparison of Morning Versus Bedtime Administration of Aspirin: A Cardiovascular Circadian Chronotherapy (C3) Trial
| NCT ID | NCT05932472 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Tor Biering-Sørensen |
| Condition | Atherosclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 32,706 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2027-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 32,706 participants in total. It began in 2024-01-15 with a primary completion date of 2027-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Manan Pareek, MD, PhD
PRINCIPAL INVESTIGATOR
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Frequently Asked Questions
Who can join the NCT05932472 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atherosclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05932472 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05932472 currently recruiting?
Yes, NCT05932472 is actively recruiting participants. Contact the research team at niklas.dyrby.johansen@regionh.dk for enrollment information.
Where is the NCT05932472 trial being conducted?
This trial is being conducted at Hellerup, Denmark.
Who is sponsoring the NCT05932472 clinical trial?
NCT05932472 is sponsored by Tor Biering-Sørensen. The principal investigator is Manan Pareek, MD, PhD at Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte. The trial plans to enroll 32,706 participants.