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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTor Biering-Sørensen

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

none

Trial design

Treatments tested in this trial

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

Treatment groups

42,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Tor Biering-Sørensen

Lead sponsor

Herlev and Gentofte Hospital

Sponsor institution

Herlev and Gentofte Hospital

Collaborator