AtherosclerosisPhase 4ASPIRIN-C3NCT05932472
Randomized Comparison of Morning Versus Bedtime Administration of Aspirin: A Cardiovascular Circadian Chronotherapy (C3) Trial
A Phase 4 study testing Aspirin in people with Atherosclerosis and Cardiovascular Diseases, run by Tor Biering-Sørensen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Cardiovascular Diseases, Drug Effect
- What is being tested?
- Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32,706 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2024to 15 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- There are no exclusion criteria for this trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Hellerup, 2900
Niklas Dyrby Johansen, MD, +4520204794, niklas.dyrby.johansen@regionh.dk
Manan Pareek, MD, PhD, +4525536900, mananpareek@dadlnet.dk
About this study
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.
Read the 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.
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Drug Effect
- Being tested
- Aspirin
- Keywords
- Aspirin, Cardiovascular Disease, Prevention, Circadian Rhythm, Randomized Controlled Trial, Pragmatic, Outcomes
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Aspirin at currently prescribed dose
| Study group | Role | What they receive |
|---|---|---|
| Aspirin at bedtime | Experimental | Participants randomized to aspirin administration at bedtime will be instructed to take their aspirin at approx. 8PM-12AM. Receives: Drug: Aspirin |
| Aspirin in the morning | Active comparator | Participants randomized to aspirin administration in the morning will be instructed to take their aspirin upon awakening or with their breakfast (approx. 6-10AM). Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of hospitalization for myocardial infarction, hospitalization for stroke, coronary revascularization, or cardiovascular death
Measured: Up to 3 years
Secondary outcomes (5)
Hospitalization for myocardial infarction
Measured: Up to 3 years
Hospitalization for stroke
Measured: Up to 3 years
Coronary revascularization
Measured: Up to 3 years
Cardiovascular death
Measured: Up to 3 years
All-cause death
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start15 Jan 2024
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32,706 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tor Biering-Sørensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tor Biering-Sørensen, Herlev and Gentofte Hospital
- Investigators
- Manan Pareek, MD, PhD, Principal investigator, Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932472
- Sponsor's protocol ID
- ASPIRIN-C3
- Acronym
- ASPIRIN-C3
- Status last verified
- Feb 2024
- First submitted
- 22 Jun 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Baseline and endpoint data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor in case of any inquiries.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Morning Versus Bedtime Administration of Aspirin: A Cardiovascular Circadian Chronotherapy (C3) Trial
- ClinicalTrials.gov ID
- NCT05932472
- Acronym / sponsor ID
- ASPIRIN-C3 / ASPIRIN-C3
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Drug Effect
- Keywords
- Aspirin, Cardiovascular Disease, Prevention, Circadian Rhythm, Randomized Controlled Trial, Pragmatic, Outcomes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32,706 participants (estimated)
- Lead sponsor
- Tor Biering-SørensenUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin at bedtime | Experimental | Drug: AspirinParticipants randomized to aspirin administration at bedtime will be instructed to take their aspirin at approx. 8PM-12AM. |
| Aspirin in the morning | Active comparator | Drug: AspirinParticipants randomized to aspirin administration in the morning will be instructed to take their aspirin upon awakening or with their breakfast (approx. 6-10AM). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAspirin at currently prescribed dose | Drug | Aspirin at bedtime, Aspirin in the morning |
Primary outcome
Composite of hospitalization for myocardial infarction, hospitalization for stroke, coronary revascularization, or cardiovascular death
Time frame: Up to 3 years
5 secondary outcomes
Hospitalization for myocardial infarction
Time frame: Up to 3 years
Hospitalization for stroke
Time frame: Up to 3 years
Coronary revascularization
Time frame: Up to 3 years
Cardiovascular death
Time frame: Up to 3 years
All-cause death
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: Yes. Baseline and endpoint data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor in case of any inquiries.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manan Pareek, MD, PhD principal investigator
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin in people with Atherosclerosis and Cardiovascular Diseases, run by Tor Biering-Sørensen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niklas Dyrby Johansen, MD (+4520204794, niklas.dyrby.johansen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of hospitalization for myocardial infarction, hospitalization for stroke, coronary revascularization, or cardiovascular death (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.