Effectiveness of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke
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: Ginkgo Diterpene Lactone Meglumine.
- Кому может быть актуально
- Состояния в реестре: Acute Ischemic Stroke. 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 →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Patients with Acute Ischemic Stroke Receiving Ginkgo Diterpene Lactone Meglumine: a Patient Registry
Обзор
The primary purpose of this study is to investigate the effectiveness of Ginkgo Diterpene Lactone Meglumine (GDLM) for patients with acute ischemic stroke (AIS) in real-world settings.
Подробное описание
The randomized controlled trial (RCT) of GDLM for the treatment of AIS was published in JAMA Network Open, titled "Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke: A Randomized Clinical Trial." This study provided valuable insights into the efficacy and safety of GDLM in improving functional recovery for patients with AIS. However, the generalizability of these findings to real-world medical settings remains unclear, as the trial was conducted under controlled conditions that may not fully reflect routine clinical practice. To address this gap, we will conduct this study to further explore the effectiveness of GDLM in a real medical environment. Using routine clinical care data for real-world evidence, we aim to investigate the treatment's impact on a broader and more diverse patient population. This approach will allow us to better understand the practical application of GDLM in everyday clinical settings, including its potential benefits and challenges when used outside the confines of a RCT.
Вмешательства
- Препарат Ginkgo Diterpene Lactone Meglumine
The specific administration protocol (including time of initiation, dosage, and treatment duration) should be strictly adhered to as per the physician's prescription and meticulously documented in the case report forms (CRFs).
Первичные конечные точки
- Proportion of patients with an mRS score of 0 or 1 [Срок оценки: on day 90 after onset]
Вторичные конечные точки (5)
- Proportion of patients with an mRS score of 2 or less [Срок оценки: on day 90 after onset]
- Distribution of mRS scores [Срок оценки: on day 90 after onset]
- Incidence of new-onset stroke events (ischemic stroke or hemorrhagic stroke) [Срок оценки: within 90 days after onset]
- Mortality rate [Срок оценки: within 90 days after onset]
- Incidence of severe or moderate bleeding events (as defined by GUSTO criteria) [Срок оценки: during hospital stay (up to 14 days)]
Критерии участия
Критерии включения
- aged ≥18 years, regardless of gender
- within 48 hours of stroke onset of ischemic stroke
- patient or their legally authorized representative (LAR) has signed informed consent or legally authorized oral consent with documentation
Критерии исключения
- mRS score of 2 or more prior to onset
- total hospital stay less than 7 days
- use of other ginkgo-derived preparations except GDLM
- current or planned participation in any other interventional clinical trials
- inability to comply with study procedures due to documented psychiatric disorders or severe cognitive impairment
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 10 центров
- Gansu Provincial People's Hospital — Lanzhou
- Harbin Second Hospital — Харбин
- The Fourth Affiliated Hospital of Harbin Medical University — Харбин
- Henan Provincial People's Hospital — Чжэнчжоу
- Jiangsu Geriatric Hospital — Нанкин
- Jiangsu Provincial Hospital of Traditional Chinese Medicine — Нанкин
- Xuzhou Hospital of Traditional Chinese Medicine — Xuzhou
- The First Hospital of Jilin University — Changchun
- … и ещё 2 центра
Идентификаторы
NCT: NCT06861426 · 2024-DZMEC-606-01 · 2022YFC3501104