ASPIrin in Reducing Events in Dialysis ( ASPIRED )
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 100 mg Oral Tablet, Matching Placebo.
- Кому может быть актуально
- Состояния в реестре: CKD (Chronic Kidney Disease) Stage 5D. 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
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
ASPIrin in Reducing Events in Dialysis
Обзор
People with kidney failure requiring dialysis have a much higher risk of developing cardiovascular (CV) disease compared with the general population. A cardiac cause accounts for 58% of all deaths in patients with end stage kidney disease (ESKD). At the same time, this population has increased risks of clotting as well as bleeding episodes. While aspirin is known to reduce cardiovascular complications in the general population, evidence to support the use of aspirin in people with ESKD receiving dialysis therapy is currently lacking. The ASPIrin to Reduce Event in Dialysis (ASPIRED) trial will test whether aspirin use in dialysis patients safely improves outcomes compared with no aspirin use.
Подробное описание
ASPIRED is an investigator-initiated, multi-center, double-blind, parallel group, event-driven, pragmatic, registry-based randomized controlled trial that will define the value of low dose aspirin (100 mg daily) on cardiovascular events in people with ESKD receiving dialysis.
The study will be conducted using the existing platform of the Chinese peritoneal dialysis (PD) and hemodialysis (HD) Dialysis Registry to screen, recruit and to collect study data as part of patient's routine clinical care during dialysis to improve efficiency and to minimize cost of a clinical trial.
ASPIRED is an event driven trial with an anticipated duration of approximately 5 years.
Randomization will be performed using a web-based system via a pass word protected encrypted website interface.
The study procedure utilizes routine six-monthly clinic visits for study follow-up to increase efficiency and minimize the burden on participants.
The analysis will be based on intention-to-treat principles. An independent Data Safety and Monitoring Board (DSMB) will established to monitor the study for safety and efficacy.
Вмешательства
- Препарат Aspirin 100 mg Oral Tablet
Aspirin 100 mg tablet daily - Препарат Matching Placebo
Matching Placebo 1 pill daily
Первичные конечные точки
- Number of Participants with composite of major cardiovascular events (3-point MACE) [Срок оценки: From trial initiation to any event first occurrence, up to 5 years.]
Вторичные конечные точки (11)
- Number of Participants with composite of major cardiovascular events plus all-cause death [Срок оценки: From trial initiation to any event first occurrence, up to 5 years.]
- Number of Participants with composite of major cardiovascular events, hospitalised unstable angina (UA) and hospitalised transient ischaemic attack (TIA) [Срок оценки: From trial initiation to any event first occurrence, up to 5 years.]
- Number of Participants with cardiovascular death [Срок оценки: From trial initiation to any event first occurrence, up to 5 years.]
- Number of Participants with Myocardial infarction [Срок оценки: From trial initiation to any event first occurrence, up to 5 years.]
- Number of Participants with ischemic stroke [Срок оценки: From trial initiation to any event first occurrence, up to 5 years.]
- Number of Participants with all-cause death [Срок оценки: From trial initiation to any event first occurrence, up to 5 years.]
- Number of Participants with coronary revascularization [Срок оценки: From trial initiation to any event occurrence, up to 5 years.]
- Number of Participants with fistula or graft thrombosis [Срок оценки: From trial initiation to any event occurrence, up to 5 years.]
- Number of Participants with intracranial haemorrhage [Срок оценки: From trial initiation to any event occurrence, up to 5 years.]
- Number of Participants with peripheral vascular events [Срок оценки: From trial initiation to any event occurrence, up to 5 years.]
- Number of Participants with ischemic events [Срок оценки: From trial initiation to any event occurrence, up to 5 years.]
Критерии участия
Критерии включения
- Incident or prevalent adults (≥18 years old) dialysis patients are included in the Dialysis Registry.
- Commenced on dialysis with the expectation of ongoing maintenance dialysis requirement.
- Willing and able to provide informed consent for this study.
Критерии исключения
- Requirement for any form of antiplatelet agent (aspirin, glycoprotein IIb/IIIa inhibitors etc), or oral anticoagulation (warfarin, NOACs), in the view of the treating physician.
- Contraindication to aspirin, in the view of the treating physician.
- Dialysis requirement due to acute kidney injure with expectation of kidney function recovery.
- History of haemorrhagic stroke or intracranial bleed within 12 months of screening.
- Coagulopathy from any cause.
- Unable to provide informed consent.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Китай · 139 центров
- The First Affiliated Hospital of Fujian Medical University — Фучжоу
- Shanghang County Hospital — Longyan
- The First Hospital of Lanzhou University — Lanzhou
- Dongguan Donghua Hospital — Дунгуань
- Dongguan Hospital of Integrative Traditional Chinese and Western Medicine — Дунгуань
- Dongguan Houjie Hospital — Дунгуань
- Dongguan Eighth People's Hospital — Дунгуань
- Dongguan Marina Bay Center Hospital — Дунгуань
- … и ещё 131 центр
Идентификаторы
NCT: NCT04381143 · GDPH-CH-2774