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

NCT06856772 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42000

Last updated 2025-03-04

No results posted yet for this study

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.

Conditions

  • Cardiovascular Diseases (CVD)
  • Drug Effect
  • Atherosclerosis Cardiovascular Disease

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).

Sponsors & Collaborators

  • Herlev and Gentofte Hospital

    collaborator OTHER

  • Tor Biering-Sørensen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2028-03-28
Completion
2028-03-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06856772 on ClinicalTrials.gov