ASPIRIN-C3: Randomized Comparison of Morning Versus Bedtime Administration of Aspirin: A Cardiovascular Circadian Chronotherapy (C3) Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Aspirin at bedtime Participants randomized to aspirin administration at bedtime will be instructed to take their aspirin at approx. 8PM-12AM. |
Drug: Aspirin
Aspirin at currently prescribed dose
|
| 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). |
Drug: Aspirin
Aspirin at currently prescribed dose
|
Outcome Measures
Primary Outcome Measures
- Composite of hospitalization for myocardial infarction, hospitalization for stroke, coronary revascularization, or cardiovascular death [Up to 3 years]
Secondary Outcome Measures
- Hospitalization for myocardial infarction [Up to 3 years]
- Hospitalization for stroke [Up to 3 years]
- Coronary revascularization [Up to 3 years]
- Cardiovascular death [Up to 3 years]
- All-cause death [Up to 3 years]
Other Outcome Measures
- Bleeding episode requiring hospitalization [Up to 3 years]
- Hospitalization for intracranial hemorrhage [Up to 3 years]
- Hospitalization for gastrointestinal hemorrhage [Up to 3 years]
- Hospitalization for unstable angina [Up to 3 years]
- Any arterial revascularization [Up to 3 years]
- Any venous thromboembolism [Up to 3 years]
- Time of day of hospitalization for myocardial infarction [Up to 3 years]
- Time of day of hospitalization for stroke [Up to 3 years]
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Tor Biering-Sørensen
Investigators
- Principal Investigator: Manan Pareek, MD, PhD, Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ASPIRIN-C3