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Идёт набор NCT06757764

The Effect and Safety of Combined Anti-platelet Treatment in Acute Ischemic Stroke Due to Large Artery Atherosclerosis

Фаза IV С лечением Cerebral Infarction Stenosis Artery

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, Clopidogrel, Cilostazol, Placebo.
Кому может быть актуально
Состояния в реестре: Cerebral Infarction, Stenosis Artery. Базовые параметры: от 20 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
South Korea
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

The Effect and Safety of Therapy Adding Cilostazol in Acute Ischemic Stroke Due to Large Artery Atherosclerosis: CHANGE Trial

Обзор

Currently, aspirin plus clopidogrel is considered as a standard acute treatment of ischemic stroke, based on results of CHANCE and POINT trial. However, still a considerable portion of patients showed early stroke recurrence, especially in those with stroke due to large artery atherosclerosis. Cilostazol may have benefit in reducing early stroke recurrence of neurologic deterioriation. The post-hoc analysis of CSPS.com showed that use of cilostazol after 15 days of stroke was effective for preventing subsequent stroke. The effect of adding cilostazol was more effective in those with large artery atherosclerosis and those receiving clopidogrel than aspirin.

Вмешательства

  • Препарат Aspirin
    Aspirin 100mg qd (21days) * In case of stenting, aspirin will be added to cilostazol and clopidogrel until 90 days after stenting. * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd)
  • Препарат Clopidogrel
    Clopidogrel 75mg qd (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd)
  • Препарат Cilostazol
    Cilostazol SR 100mg x 2cap (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd)
  • Препарат Placebo
    Placebo x 2cap (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd)

Первичные конечные точки

  • Proportion of occurrence of composite endpoint [Срок оценки: during admission (within 14 days) and within 180 days after stroke]
Вторичные конечные точки (11)
  • Proportion of participants with good functional outcome (mRS(modified Rankin Scale) 0-2) [Срок оценки: at 180 days]
  • mRS score collected at 180 days [Срок оценки: at 180 days]
  • Proportion of participants with Neurologic Deterioration(ND) during admission [Срок оценки: during admission(within 14days)]
  • Proportion of participants with good functional outcome (mRS 0-2) [Срок оценки: at 90 days]
  • Proportion of participants with ischemic stroke recurrence [Срок оценки: at 90 days]
  • Proportion of participants with ischemic stroke recurrence [Срок оценки: at 180 days]
  • Proportion of participants with MI(Myocardial Infarction), ischemic stroke recurrence, haemorrhagic stroke and vascular death [Срок оценки: within 180 days]
  • Proportion of participants with haemorrhagic stroke [Срок оценки: within 180 days]
  • Proportion of participants with myocardial infarction [Срок оценки: within 180 days]
  • Proportion of participants with vascular death [Срок оценки: within 180 days]
  • mRS score collected at 90 days [Срок оценки: at 90 days]

Критерии участия

Критерии включения

  • Age of 20 years or older
  • Acute ischemic stroke due to large artery atherosclerosis (both including Intra and extracranial atherosclerosis) which may be defined by a ischemic lesion confirmed at diffusion-weighted image and a corresponding significant stenosis (more than 50% of diameter reduction) proximal to the ischemic lesion confirmed by MR angiography or CT angiography.
  • Informed consent obtained within 72h from stroke onset
  • Acquisition of written informed consent prior to study entry

Критерии исключения

  • Large infarction unable to start antiplatelet treatment
  • Combined with acute intracranial haemorrhage
  • With initial haemorrhagic transformation
  • Previous mRS higher than 2
  • Indicated for anticoagulation
  • Contraindication for aspirin, clopidogrel or cilostazol
  • Requirement of long term NSAID
  • Pre-planned for surgery
  • Unable to withdraw consent
  • Unavailable to participate based on judgement of the investigator
  • Participants of reproductive potential (PORP)/ Participants of childbearing potential (POCBP) who do not agree to practice methods of birth control or remain fully abstinent from sexual activity with the potential for conception.

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
Тройное слепое
Основная цель
Лечение

Центры проведения

South Korea · 24 центра
  • Asan Medical Center — Seoul
  • Pusan National University Hospital — Busan
  • Chungbuk National University Hospital — Cheongju-si
  • Kyungpook National University Chilgok Hospital — Daegu
  • Chungnam National University Hospital — Daejeon
  • Eulji University Hospital — Daejeon
  • Chonnam National University Hospital — Gwangju
  • Seoul National University Bundang Hospital — Gyeonggi-do
  • … и ещё 16 центров

Идентификаторы

NCT: NCT06757764 · CHANGE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗