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NCT Number: NCT06856772

Randomized Comparison of Morning Versus Bedtime Administration of Statins: A Cardiovascular Circadian Chronotherapy (C3) Trial

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.

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Key information

Conditions

Cardiovascular Diseases (CVD) Atherosclerosis Cardiovascular Disease Cardiovascular Diseases Drug Effect

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Hellerup, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • none

Treatment and study plan

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).

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

    Inpatient, at least 1 night

  2. 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).

    Inpatient, at least 1 night

  3. 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).

  4. 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).

Other outcomes

  1. Hospitalization for unstable angina

    Time frame: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).

    Inpatient, at least 1 night

  2. 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).

  3. 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).

  4. 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).

    The incidence of Any venous thromboembolism

  5. Hospitalization for heart failure

    Time frame: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).

    The incidence of Hospitalization for heartfailure. For hospitalizations: Inpatient, at least 1 night

  6. Hospitalization for rhabdomyolysis

    Time frame: From date of randomization until end of study (up til 5 years)

    The incidence of Hospitalization for rhabdomyolysis, Inpatient, at least 1 night.

  7. Any incident cancer

    Time frame: From date of randomization until end of study (up til 5 years)

    The incidence of any cancer

  8. Any incident renal disorder

    Time frame: From date of randomization until end of study (up til 5 years)

    The incidence of any renal disorder

  9. Any incident hepatic disorder

    Time frame: From date of randomization until end of study (up til 5 years)

    The incidence of any hepatic disorder

  10. Bleeding episodes requiring hospitalization

    Time frame: From date of randomization until end of study (up til 5 years)

    The incidence of any bleeding episodes requiring hospitalization. For hospitalizations: Inpatient, at least 1 night.

  11. Any Incident Diabetes mellitus

    Time frame: From date of randomization until end of study (up til 5 years)

    The incidence of diabetes mellitus

  12. Plasma Lipid levels

    Time frame: From date of randomization until end of study (up til 5 years)

  13. Plasma C-reactive protein level

    Time frame: From date of randomization until end of study (up til 5 years)

  14. Time of day of hospitalization for myocardial infarction

    Time frame: From date of randomization until end of study (up til 5 years)

    The time of hospitalization will be expressed as the hour of the beginning of the hospitalization

  15. Time of day of hospitalization for stroke

    Time frame: From date of randomization until end of study (up til 5 years)

    The time of hospitalization will expressed as the hour of the beginning of the hospitalization.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Tor Biering-Sørensen

Other

Collaborators

  • Herlev and Gentofte Hospital

Registry information

Acronym: STATIN-C3

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 4, 2025
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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