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Набор скоро начнётся NCT07604298

Efficacy and Safety of Indobufen, Aspirin, Cilostazol and Clopidogrel in the Treatment of Ischemic Stroke

— Наблюдательное 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: indubufen, aspirin, clopidogrel, cilostazol.
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 →

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Официальное название

Efficacy and Safety of Indobufen, Aspirin, Cilostazol, and Clopidogrel in the Treatment of Ischemic Stroke: a Single-center, Retrospective Study

Обзор

Through a single-center retrospective cohort study of acute ischemic stroke (AIS) patients receiving secondary prevention with indobufen, clopidogrel, cilostazol, or aspirin as monotherapy or dual therapy, we aim to compare the real-world effectiveness and safety of these four antiplatelet regimens. Through closely tracking the recurrence of stroke (including ischemic and hemorrhagic stroke) and bleeding events (GUSTO-defined) within one year of treatment, we evaluate the association between each antiplatelet agent and the risk of stroke recurrence, thereby providing critical evidence to guide individualized antiplatelet therapy in AIS patients.

Подробное описание

Stroke is the second leading cause of death and the third leading cause of disability worldwide, with a 5%-10% one-year recurrence rate after acute ischemic stroke (AIS), making effective secondary prevention critical. Indobufen, aspirin, clopidogrel, and cilostazol-as monotherapy or in combination-constitute the main antiplatelet strategies for secondary prevention of ischemic stroke. Guidelines recommend early clopidogrel-aspirin dual therapy for mild stroke or TIA, while aspirin remains standard for moderate-to-severe cases, though it carries gastrointestinal and bleeding risks. Clopidogrel may be resistant due to CYP2C19 loss-of-function alleles in Asian populations. Cilostazol may be suitable for patients with CYP2C19-deficiency but has an uncertain intracranial bleeding risk. Indobufen, a reversible COX inhibitor, offers lower bleeding risk and fewer gastrointestinal adverse effects, yet lacks large-scale head-to-head trials against the other agents. Thus, real-world evidence to guide optimal antiplatelet selection for diverse ischemic stroke patients is lacking. This study aims to compare the effectiveness and safety of these four agents (monotherapy or guideline-recommended dual therapy) for secondary prevention of ischemic stroke, providing hypothesis-generating evidence for future prospective research.

Вмешательства

  • Препарат indubufen, aspirin, clopidogrel, cilostazol
    Dosage, Frequency: Indobufen (200 mg twice daily); Aspirin (100 mg once daily); Cilostazol (100 mg twice daily); Clopidogrel (75 mg once daily). Dual antiplatelet therapy (DAPT) with two of these agents was permitted if clinically indicated, as per the treating physician's judgment.

Первичные конечные точки

  • Incidence of composite events, including any new stroke or bleeding events [Срок оценки: Within 1 year of treatment]
Вторичные конечные точки (6)
  • Incidence of new cardiovascular events and death [Срок оценки: Within 1 year]
  • GUSTO-defined bleeding events of all grades [Срок оценки: Within 1 year]
  • National Institutes of Health Stroke Scale (NHISS) score [Срок оценки: Within 1 year of treatment]
  • Modified Rankin Scale ( mRS ) score [Срок оценки: Within 1 year of treatment]
  • Barthel Index [Срок оценки: Within 1 year of treatment]
  • Drug-related adverse events [Срок оценки: Within 1 year of treatment]

Критерии участия

Критерии включения

  • Age ≥ 18 years;
  • Diagnosed with acute ischemic stroke (AIS) patients according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018 ;
  • Hospitalized in the Department of Neurology, Nanfang Hospital, Southern Medical University, between January 2020 and December 2025;
  • Received one of the following as a secondary prevention regimen within 7 days after discharge: indobufen, aspirin, clopidogrel, or cilostazol, either as monotherapy or as dual therapy;
  • Have follow-up records at 1 year after treatment initiation.

Критерии исключения

  • Already having long-term anticoagulant therapy at baseline;
  • History of hemorrhagic stroke or active bleeding;
  • Severe hepatic or renal dysfunction (defined as AST/ALT > 3 times the upper limit of normal, or estimated glomerular filtration rate < 30 mL/min/1.73m²), end-stage disease, intracranial tumor, or intracranial infection.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Nanfang Hospital,Southern Medical University Recruiting — Гуанчжоу

Идентификаторы

NCT: NCT07604298 · NFEC-2026-179

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗