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Набор скоро начнётся NCT06112028

Clinical Study of Tongxinluo Capsule in Preventing and Treating Restenosis After Intracranial and External Arterial Stenting

Фаза IV С лечением Stent Restenosis

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: Tongxinluo capsule, Primary therapy.
Кому может быть актуально
Состояния в реестре: Stent Restenosis. Базовые параметры: 45 лет — 80 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Intrastent restenosis is a common complication after intracranial and extracranial arterial stenting and an important cause of recurrent ischemic stroke. Studies have shown that Tongxinluo capsule can protect the injured inner cells, reduce inflammation, inhibit the proliferation and migration of smooth muscle cells, inhibit the proliferation of plaque and nourish blood vessels, and resist arteriosclerosis. This study was a multicenter prospective randomized controlled clinical trial. Participants with intracranial and extracranial atherosclerotic stenosis who successfully underwent arterial stenting were included in the study, and were divided into Tongxinluo test group and control group. Clinical and related auxiliary examination data were collected at each follow-up point. To explore the effectiveness and potential mechanism of Tongxinluo capsule in preventing and treating restenosis after intracranial and external arterial stenting, and to provide reference for expanding clinical use of traditional Chinese medicine.

Подробное описание

Study participants aged 45-80 years who met the criteria for symptomatic or asymptomatic cerebral artery stenosis and successfully underwent cerebrovascular stenting were randomly divided into test group and control group. On the basis of routine oral treatment ,participants in experimental group were given Tongxinluo capsule. The control group received routine oral treatment. The routine follow-up sites were 1, 3, 6 and 12 months, and clinical data and blood were collected at the initial diagnosis and each follow-up site. SPSS software was used to analyze whether Tongxinluo capsule could reduce restenosis after intracranial and extracranial arterial stenting. During the follow-up, the adverse reactions such as bleeding and gastrointestinal tract were observed.

Вмешательства

  • Препарат Tongxinluo capsule
    On the basis of conventional treatment, the study participants in the experimental group were given Tongxinluo capsule for 12 months.
  • Другое Primary therapy
    Routine oral aspirin enteric-coated tablets, clopidogrel bisulfate tablets and rosuvastatin calcium tablets (or atorvastatin calcium tablets)

Первичные конечные точки

  • Changes of vascular stenosis rate after intracranial and extracranial arterial stenting [Срок оценки: The 12th month]

Критерии участия

Критерии включения

  • The diagnosis of symptomatic cerebral artery stenosis study participants met the above diagnostic criteria; Participants in the study with asymptomatic cerebral artery stenosis or asymptomatic cerebral artery stenosis met the indications for stent implantation in the Chinese Guidelines for Intravascular Interventional Treatment of Ischemic Cerebrovascular Diseases 2015, and successfully underwent cerebrovascular stenting (residual stenosis after vascular opening ≤30% after stent implantation).
  • I am 45-80 years old and I and my family members agree to participate in this study.
  • It can tolerate statin and platelet therapy without serious complications.

Критерии исключения

  • Patients with other intracranial lesions;
  • Recent bleeding history or bleeding tendency;
  • Patients with severe cardiac, liver and renal insufficiency, hypertension and diabetes were not well controlled;

(4) Severe symptoms of stroke or neurological impairment and unstable symptoms after surgery;

(5) Severely infected persons who cannot be controlled;

⑥ Patients who stop taking medicine for more than 2 months for various reasons;

⑦ Taking proprietary Chinese medicine or traditional Chinese medicine with similar efficacy.

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
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06112028 · 07

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗