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NOT YET RECRUITING
NCT06856772
PHASE4

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

Sponsor: Tor Biering-Sørensen

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

42000

Start Date

2025-02-28

Completion Date

2028-03-28

Last Updated

2025-03-04

Healthy Volunteers

No

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).

Locations (1)

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Hellerup, Denmark