Cardiovascular Diseases (CVD)Phase 4STATIN-C3NCT06856772
Randomized Comparison of Morning Versus Bedtime Administration of Statins: A Cardiovascular Circadian Chronotherapy (C3) Trial
A Phase 4 study testing Statin in the evening (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin) and Statin in the morning (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin) in people with Cardiovascular Diseases (CVD) and Drug Effect, run by Tor Biering-Sørensen at 1 site in Denmark.
Trial summary
Statins inhibit hydroxy-methylglutaryl coenzyme A (HMG-CoA) reductase which catalyzes the rate-limiting step in cholesterol synthesis. This in turn leads to reductions in concentrations of low-density lipoprotein (LDL) cholesterol and C-reactive protein which reduces the risk of incident atherosclerotic events among… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases (CVD), Drug Effect, Atherosclerosis Cardiovascular Disease
- What is being tested?
- Statin in the evening (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin) and Statin in the morning (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42,000 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Feb 2025to 28 Mar 2028
- 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 treatment with atorvastatin 10-80 mg, rosuvastatin 5-40 mg, simvastatin 10-80 mg or pravastatin 20-40 mg (as recorded in the Danish National Prescription Registry and confirmed by the participant via questionnaire)
- Signed informed consent
Who cannot join
- none
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
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Hellerup, 2900
Sine Højlund Christensen, MSc, +4524595177, sine.hoejlund.christensen@regionh.dk
Niklas Dyrby Johansen, MD, PhD, +4520204794, niklas.dyrby.johansen@regionh.dk
About this study
Statins inhibit hydroxy-methylglutaryl coenzyme A (HMG-CoA) reductase which catalyzes the rate-limiting step in cholesterol synthesis. This in turn leads to reductions in concentrations of low-density lipoprotein (LDL) cholesterol and C-reactive protein which reduces the risk of incident atherosclerotic events among individuals both with and without a history of atherosclerotic cardiovascular Several pilot studies have suggested potential benefits of taking statin in the evening rather than in the morning.
The primary objective of this study is to examine whether statin 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 statin.
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 statin treatment regardless of the presence or absence of established cardiovascular disease. Participants will be randomized 1:1 to either statin administration at bedtime or in the morning. The trial is event-driven.
- Being tested
- Statin in the evening (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin), Statin in the morning (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)
- Keywords
- Statin, Circadian Rhythm, Randomized Controlled Trial, Pragmatic, Outcomes, Cardiovascular disease, Prevention
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Statin in the evening (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)Drug
Participants will be instructed to take their Statin daily at approx. 8PM-12AM.
Statin in the morning (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)Drug
Participants will be instructed to take their statin upon awakening/or with their breakfast (approx. 6AM-10AM).
| Study group | Role | What they receive |
|---|---|---|
| Statin at bedtime | Experimental | Statin in the current prescribed dose Receives: Drug: Statin in the evening (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin) |
| Statin in the morning | Experimental | Statin in the current prescribed dose Receives: Drug: Statin in the morning (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin) |
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 or cardiovascular death
For Hospitalizations: Inpatient, at least 1 night
Measured: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
Secondary outcomes (4)
Hospitalization for myocardial infarction
Inpatient, at least 1 night
Measured: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
Hospitalization for stroke
Inpatient, at least 1 night
Measured: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
Cardiovascular death
Measured: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
All-cause death
Measured: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start28 Feb 2025 (estimated)
- Primary completion28 Mar 2028 (estimated)
- Study completion28 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Diseases (CVD)Studies 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
- 42,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tor Biering-Sørensen
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev and Gentofte Hospital
- Responsible party
- Sponsor-investigator, Tor Biering-Sørensen, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856772
- Sponsor's protocol ID
- STATIN-C3
- Acronym
- STATIN-C3
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Morning Versus Bedtime Administration of Statins: A Cardiovascular Circadian Chronotherapy (C3) Trial
- ClinicalTrials.gov ID
- NCT06856772
- Acronym / sponsor ID
- STATIN-C3 / STATIN-C3
- Keywords
- Statin, Circadian Rhythm, Randomized Controlled Trial, Pragmatic, Outcomes, Cardiovascular disease, Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42,000 participants (estimated)
- Lead sponsor
- Tor Biering-SørensenUniversity, hospital or other
- Collaborators
- Herlev and Gentofte Hospital
- Study start
- 28 Feb 2025 (estimated)
- Primary completion
- 28 Mar 2028 (estimated)
- Study completion
- 28 Mar 2028 (estimated)
- First posted
- 4 Mar 2025 (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.
Statins inhibit hydroxy-methylglutaryl coenzyme A (HMG-CoA) reductase which catalyzes the rate-limiting step in cholesterol synthesis. This in turn leads to reductions in concentrations of low-density lipoprotein (LDL) cholesterol and C-reactive protein which reduces the risk of incident atherosclerotic events among individuals both with and without a history of atherosclerotic cardiovascular Several pilot studies have suggested potential benefits of taking statin in the evening rather than in the morning.
The primary objective of this study is to examine whether statin 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 statin.
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 statin treatment regardless of the presence or absence of established cardiovascular disease. Participants will be randomized 1:1 to either statin 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 |
|---|---|---|
| Statin at bedtime | Experimental | Drug: Statin in the evening (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)Statin in the current prescribed dose |
| Statin in the morning | Experimental | Drug: Statin in the morning (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)Statin in the current prescribed dose |
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 treatment with atorvastatin 10-80 mg, rosuvastatin 5-40 mg, simvastatin 10-80 mg or pravastatin 20-40 mg (as recorded in the Danish National Prescription Registry and confirmed by the participant via questionnaire)
- Signed informed consent
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Statin in the evening (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)Participants will be instructed to take their Statin daily at approx. 8PM-12AM. | Drug | Statin at bedtime |
| Statin in the morning (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)Participants will be instructed to take their statin upon awakening/or with their breakfast (approx. 6AM-10AM). | Drug | Statin in the morning |
Primary outcome
Composite of hospitalization for myocardial infarction, hospitalization for stroke or cardiovascular death
Time frame: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
For Hospitalizations: Inpatient, at least 1 night
4 secondary outcomes
Hospitalization for myocardial infarction
Time frame: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
Hospitalization for stroke
Time frame: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
Cardiovascular death
Time frame: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
All-cause death
Time frame: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 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 4 Mar 2025.
- 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.
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 Statin in the evening (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin) and Statin in the morning (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin) in people with Cardiovascular Diseases (CVD) and Drug Effect, 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: opening soon, as of the sponsor's last update on 4 Mar 2025. 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 Manan Pareek, MD and PhD (+4525536900, mananpareek@dadlnet.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 or cardiovascular death (time frame: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 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 4 Mar 2025.