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

Tor Biering-Sørensen

Status and phase: Not yet enrolling; Phase 4

Conditions: Atherosclerosis Cardiovascular Disease; Drug Effect; Cardiovascular Diseases (CVD)

Treatments: Drug: Statin in the morning (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin); Drug: Statin in the evening (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)

Study type: Interventional

Funder types: Other

Identifiers

NCT06856772

STATIN-C3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42,000 participants in 2 patient groups

Statin at bedtime

Experimental group

Description:

Statin in the current prescribed dose

Treatment:

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

Statin in the morning

Experimental group

Description:

Statin in the current prescribed dose

Treatment:

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