Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Herlev and Gentofte Hospital | OTHER |
Not provided
Not provided
Not provided
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.
The study is a pragmatic, registry-based, open-label, randomized controlled trial combining the utilization of the Danish nationwide health registries and the official Danish electronic letter system (Digital Post/eBoks) into an innovative, decentralized trial requiring no study visits from participants. The nationwide health registries will be used for identification of potential participants and data collection, including baseline information and follow-up data, while the electronic letter system will be used for sending recruitment letters and communicating with participants. Study participants will provide electronic informed consent from home before inclusion and randomization.
The trial will include patients currently in statin treatment regardless of the presence or absence of established cardiovascular disease. Participants will be randomized 1:1 to either statin administration at bedtime or in the morning. The trial is event-driven.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Statin at bedtime | Experimental | Statin in the current prescribed dose |
|
| Statin in the morning | Experimental | Statin in the current prescribed dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Statin in the evening (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin) | Drug | Participants will be instructed to take their Statin daily at approx. 8PM-12AM. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of hospitalization for myocardial infarction, hospitalization for stroke or cardiovascular death | For Hospitalizations: Inpatient, at least 1 night | Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization for myocardial infarction | Inpatient, at least 1 night | Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years). |
| Hospitalization for stroke |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization for unstable angina | Inpatient, at least 1 night | Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years). |
| Coronary revascularization |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manan Pareek, MD and PhD | Contact | +4525536900 | mananpareek@dadlnet.dk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte | Hellerup | 2900 | Denmark |
Baseline and endpoint data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor in case of any inquiries.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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). |
|
Inpatient, at least 1 night
| Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years). |
| Cardiovascular death | Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years). |
| All-cause death | Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years). |
| Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years). |
| Any arterial revascularization | Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years). |
| Any venous thromboembolism | The incidence of Any venous thromboembolism | Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years). |
| Hospitalization for heart failure | The incidence of Hospitalization for heartfailure. For hospitalizations: Inpatient, at least 1 night | Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years). |
| Hospitalization for rhabdomyolysis | The incidence of Hospitalization for rhabdomyolysis, Inpatient, at least 1 night. | From date of randomization until end of study (up til 5 years) |
| Any incident cancer | The incidence of any cancer | From date of randomization until end of study (up til 5 years) |
| Any incident renal disorder | The incidence of any renal disorder | From date of randomization until end of study (up til 5 years) |
| Any incident hepatic disorder | The incidence of any hepatic disorder | From date of randomization until end of study (up til 5 years) |
| Bleeding episodes requiring hospitalization | The incidence of any bleeding episodes requiring hospitalization. For hospitalizations: Inpatient, at least 1 night. | From date of randomization until end of study (up til 5 years) |
| Any Incident Diabetes mellitus | The incidence of diabetes mellitus | From date of randomization until end of study (up til 5 years) |
| Plasma Lipid levels | From date of randomization until end of study (up til 5 years) |
| Plasma C-reactive protein level | From date of randomization until end of study (up til 5 years) |
| Time of day of hospitalization for myocardial infarction | The time of hospitalization will be expressed as the hour of the beginning of the hospitalization | From date of randomization until end of study (up til 5 years) |
| Time of day of hospitalization for stroke | The time of hospitalization will expressed as the hour of the beginning of the hospitalization. | From date of randomization until end of study (up til 5 years) |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| D019821 | Simvastatin |
| D000069059 | Atorvastatin |
| D000068718 | Rosuvastatin Calcium |
| D017035 | Pravastatin |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
Not provided
Not provided