Набор скоро начнётся NCT06856772

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

Фаза IV С лечением Cardiovascular Diseases (CVD) Drug Effect Atherosclerosis Cardiovascular Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Statin in the evening (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin), Statin in the morning (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin).
Кому может быть актуально: Состояния в реестре: Cardiovascular Diseases (CVD), Drug Effect, Atherosclerosis Cardiovascular Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Дания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

Composite of hospitalization for myocardial infarction, hospitalization for stroke or cardiovascular death [Срок оценки: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).]

Вторичные конечные точки (4)

Hospitalization for myocardial infarction [Срок оценки: 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 [Срок оценки: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).]
Cardiovascular death [Срок оценки: 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 [Срок оценки: Will be assessed in a time-to-first-event approach from date of randomization until end of study (up til 5 years).]

Критерии участия

Критерии включения

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