Идёт набор NCT05932472

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

Фаза IV С лечением Atherosclerosis Cardiovascular Diseases Drug Effect

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: Aspirin.
Кому может быть актуально: Состояния в реестре: Atherosclerosis, Cardiovascular Diseases, Drug Effect. 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

Wide variability in the antiplatelet effects of aspirin may lead to recurrent thromboembolic events. Several pilot studies have suggested potential benefits of taking aspirin at bedtime rather than in the morning. The primary objective of this study is to examine whether aspirin 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 aspirin.

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 aspirin treatment regardless of the presence or absence of established cardiovascular disease. Participants will be randomized 1:1 to either aspirin administration at bedtime or in the morning. The trial is event-driven.

Вмешательства

Препарат Aspirin
Aspirin at currently prescribed dose

Первичные конечные точки

Composite of hospitalization for myocardial infarction, hospitalization for stroke, coronary revascularization, or cardiovascular death [Срок оценки: Up to 3 years]

Вторичные конечные точки (5)

Hospitalization for myocardial infarction [Срок оценки: Up to 3 years]
Hospitalization for stroke [Срок оценки: Up to 3 years]
Coronary revascularization [Срок оценки: Up to 3 years]
Cardiovascular death [Срок оценки: Up to 3 years]
All-cause death [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

Age >=18 years
Current chronic treatment with aspirin (as recorded in the Danish National Prescription Registry and confirmed by the participant via questionnaire)
Signed informed consent