| Registry | NCT06856772, acronym STATIN-C3 |
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| Status | Not yet recruiting |
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| Phase | Phase 4 |
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| Study type | Interventional; randomized, parallel, masking: none, treatment |
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| Enrollment | 42000 (Estimated) |
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| Sponsor | Tor Biering-Sørensen (Other); collaborators: Herlev and Gentofte Hospital |
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| Conditions | Cardiovascular Diseases (CVD), Drug Effect, Atherosclerosis Cardiovascular Disease |
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| Interventions | Statin in the evening (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin), Statin in the morning (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin) (Drug) |
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| Dates | start 2025-02-28 (estimated), primary completion 2028-03-28 (estimated), completion 2028-03-28 (estimated), first posted 2025-03-04, last updated 2025-03-04 |
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| Locations | 1 site in Denmark |
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Related Papers Related Patents Related Grants Related Experts
All trials for Cardiovascular Diseases (CVD) All trials for Drug Effect All trials of Statin in the evening (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin) All trials of Statin in the morning (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)
-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 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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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| 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 |
- 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).
+Outcome measures
Primary outcomes
- Composite of hospitalization for myocardial infarction, hospitalization for stroke or cardiovascular death [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
- Hospitalization for myocardial infarction [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
- Hospitalization for stroke [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
- Cardiovascular death [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 [Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).]
Other outcomes
- Hospitalization for unstable angina [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
- Coronary revascularization [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 [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 [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
- Hospitalization for heart failure [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
- Hospitalization for rhabdomyolysis [From date of randomization until end of study (up til 5 years)]: The incidence of Hospitalization for rhabdomyolysis, Inpatient, at least 1 night.
- Any incident cancer [From date of randomization until end of study (up til 5 years)]: The incidence of any cancer
- Any incident renal disorder [From date of randomization until end of study (up til 5 years)]: The incidence of any renal disorder
- Any incident hepatic disorder [From date of randomization until end of study (up til 5 years)]: The incidence of any hepatic disorder
- Bleeding episodes requiring hospitalization [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.
- Any Incident Diabetes mellitus [From date of randomization until end of study (up til 5 years)]: The incidence of diabetes mellitus
- Plasma Lipid levels [From date of randomization until end of study (up til 5 years)]
- Plasma C-reactive protein level [From date of randomization until end of study (up til 5 years)]
- Time of day of hospitalization for myocardial infarction [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
- Time of day of hospitalization for stroke [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.
+Eligibility
Sex: All, ages: 18 Years to any
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
+Locations (1)
| Facility | City | Country | Status |
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| Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte | Hellerup | Denmark | |