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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

42000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2028-03-28

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases (CVD) Drug Effect Atherosclerosis Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Statin at bedtime

Statin in the current prescribed dose

Group Type EXPERIMENTAL

Statin in the evening (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)

Intervention Type DRUG

Participants will be instructed to take their Statin daily at approx. 8PM-12AM.

Statin in the morning

Statin in the current prescribed dose

Group Type EXPERIMENTAL

Statin in the morning (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)

Intervention Type DRUG

Participants will be instructed to take their statin upon awakening/or with their breakfast (approx. 6AM-10AM).

Interventions

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Statin in the evening (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)

Participants will be instructed to take their Statin daily at approx. 8PM-12AM.

Intervention Type 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).

Intervention Type DRUG

Eligibility Criteria

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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