Randomized Comparison of Morning Versus Bedtime Administration of Statins: A Cardiovascular Circadian Chronotherapy (C3) Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Statin in the evening (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin), Statin in the morning (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin).
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases (CVD), Drug Effect, Atherosclerosis Cardiovascular Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug 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 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).
Primary outcome measures
- 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).]
Secondary outcome measures (4)
- 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).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiol — Hellerup
Identifiers
NCT: NCT06856772 · STATIN-C3