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

ConditionsCardiovascular Diseases (CVD)Drug EffectAtherosclerosis Cardiovascular Disease
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

    Drug

    Participants will be instructed to take their Statin daily at approx. 8PM-12AM.

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

    Drug

    Participants will be instructed to take their statin upon awakening/or with their breakfast (approx. 6AM-10AM).

Treatment groups

42,000 Participants
are divided into 2 treatment groups
Group A: Statin at bedtimeExperimental treatment 1 intervention
Group B: Statin in the morningExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Composite of hospitalization for myocardial infarction, hospitalization for stroke or cardiovascular death

For Hospitalizations: Inpatient, at least 1 night

Time frame
Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).

Secondary outcomes

1

Hospitalization for myocardial infarction

Inpatient, at least 1 night

Time frame
Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
2

Hospitalization for stroke

Inpatient, at least 1 night

Time frame
Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
3

Cardiovascular death

Time frame
Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
4

All-cause death

Time frame
Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).

Other outcomes

1

Hospitalization for unstable angina

Inpatient, at least 1 night

Time frame
Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
2

Coronary revascularization

Time frame
Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
3

Any arterial revascularization

Time frame
Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).
4

Any venous thromboembolism

The incidence of Any venous thromboembolism

Time frame
Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tor Biering-Sørensen

Lead sponsor

Herlev and Gentofte Hospital

Sponsor institution

Herlev and Gentofte Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: