Clinical Trial

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

Study acronym: STATIN-C3
Not Yet Recruiting Phase 4
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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.
Trial Details
NCT Number NCT06856772
Lead Sponsor Tor Biering-Sørensen
Collaborators: Herlev and Gentofte Hospital
Conditions Cardiovascular Diseases (CVD), Drug Effect, Atherosclerosis Cardiovascular Disease
Enrollment 42,000 participants
Start Date 2025-02-28
Primary Completion 2028-03-28 (estimated)
Study Completion 2028-03-28 (estimated)
Updated on ClinicalTrials.gov 2025-03-04