NCT Number: NCT06856772
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Hellerup, 2900, Denmark
Manan Pareek, MD and PhD
PRINCIPAL_INVESTIGATOR
Niklas Dyrby Johansen, MD, PhD
CONTACT
Sine Højlund Christensen, MSc
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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
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
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
Time frame: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
Time frame: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
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
Time frame: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
Time frame: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
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
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
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.
Time frame: From date of randomization until end of study (up til 5 years)
The incidence of any cancer
Time frame: From date of randomization until end of study (up til 5 years)
The incidence of any renal disorder
Time frame: From date of randomization until end of study (up til 5 years)
The incidence of any hepatic disorder
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.
Time frame: From date of randomization until end of study (up til 5 years)
The incidence of diabetes mellitus
Time frame: From date of randomization until end of study (up til 5 years)
Time frame: From date of randomization until end of study (up til 5 years)
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
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.
Contact information is provided by the study sponsor or research team.
Tor Biering-Sørensen
Other
Acronym: STATIN-C3
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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