drugset / Trial / NCT06856772

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

NCT06856772

Phase 4 Not yet recruiting 42000 enrolled Tor Biering-Sørensen Herlev and Gentofte Hospital · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule Oral
Subject Pravastatin Small molecule Oral
Subject Rosuvastatin Small molecule Oral
Subject Simvastatin Small molecule Oral