A Phase 4 interventional study of Statin in the evening (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin) and Statin in the morning (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin) in Cardiovascular Diseases (CVD), Drug Effect and Atherosclerosis Cardiovascular Disease, sponsored by Tor Biering-Sørensen. Not yet recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-04.
Sponsored by Tor Biering-Sørensen · Phase 4, Interventional, and Treatment
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.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 42,000 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Tor Biering-Sørensen is the lead sponsor of 22 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Statin in the current prescribed dose
Drug: Statin in the evening (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)
Statin in the current prescribed dose
Drug: Statin in the morning (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)
Participants will be instructed to take their Statin daily at approx. 8PM-12AM.
Participants will be instructed to take their statin upon awakening/or with their breakfast (approx. 6AM-10AM).
Composite of hospitalization for myocardial infarction, hospitalization for stroke or cardiovascular death
For Hospitalizations: Inpatient, at least 1 night
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 myocardial infarction
Inpatient, at least 1 night
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
Inpatient, at least 1 night
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).
Hospitalization for unstable angina
Inpatient, at least 1 night
Time frame: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
Coronary revascularization
Time frame: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
Any arterial revascularization
Time frame: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
Any venous thromboembolism
The incidence of Any venous thromboembolism
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 heart failure
The incidence of Hospitalization for heartfailure. For hospitalizations: Inpatient, at least 1 night
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 rhabdomyolysis
The incidence of Hospitalization for rhabdomyolysis, Inpatient, at least 1 night.
Time frame: From date of randomization until end of study (up til 5 years)
Any incident cancer
The incidence of any cancer
Time frame: From date of randomization until end of study (up til 5 years)
Any incident renal disorder
The incidence of any renal disorder
Time frame: From date of randomization until end of study (up til 5 years)
Any incident hepatic disorder
The incidence of any hepatic disorder
Time frame: From date of randomization until end of study (up til 5 years)
Bleeding episodes requiring hospitalization
The incidence of any bleeding episodes requiring hospitalization. For hospitalizations: Inpatient, at least 1 night.
Time frame: From date of randomization until end of study (up til 5 years)
Any Incident Diabetes mellitus
The incidence of diabetes mellitus
Time frame: From date of randomization until end of study (up til 5 years)
Plasma Lipid levels
Time frame: From date of randomization until end of study (up til 5 years)
Plasma C-reactive protein level
Time frame: From date of randomization until end of study (up til 5 years)
Time of day of hospitalization for myocardial infarction
The time of hospitalization will be expressed as the hour of the beginning of the hospitalization
Time frame: From date of randomization until end of study (up til 5 years)
Time of day of hospitalization for stroke
The time of hospitalization will expressed as the hour of the beginning of the hospitalization.
Time frame: From date of randomization until end of study (up til 5 years)
Plan to share: 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tor Biering-Sørensen