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

Condition(s) studied

Investigational drug(s) / intervention(s)

Statin in the evening (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin): Participants will be instructed to take their Statin daily at approx. 8PM-12AM.

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).

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.

Eligibility

Primary outcome measure(s)

• Composite of hospitalization for myocardial infarction, hospitalization for stroke or cardiovascular death — Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
  For Hospitalizations: Inpatient, at least 1 night

Trial sites (1)

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