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Набор скоро начнётся NCT07203846

Modulation of Gut MicroFLORA With Rifaximin to Reduce High Platelet Reactivity in Post-ACS Patients on Ticagrelor

Фаза IV С лечением ACS - Acute Coronary Syndrome Ticagrelor Microbiota Platelet Aggregation

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: Rifaximin.
Кому может быть актуально
Состояния в реестре: ACS - Acute Coronary Syndrome, Ticagrelor, Microbiota, Platelet Aggregation. Базовые параметры: 18 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
Польша
Следующий шаг
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Официальное название

Modulation of Gut Microflora With Rifaximin to Reduce High Platelet Reactivity in Post-Acute Coronary Syndrome Patients on Ticagrelor (FLORA-ACS)

Обзор

The FLORA-ACS study aims to evaluate the relationship between dysbiosis and high platelet reactivity during treatment with ticagrelor in patients with a history of acute coronary syndromes and investigate the use of rifaximin to eliminate dysbiosis and thus provide effective antiplatelet treatment.

Подробное описание

A research hypothesis has been formulated indicating dysbiosis of the gut microbiota as a possible cause of high platelet reactivity (HPR) during treatment with an antiplatelet agent, ticagrelor, in post-acute coronary syndrome (ACS) patients. The use of rifaximin, an antibiotic exhibiting an eubiotic effect, may correct gut dysbiosis and help determine whether changes in the microbiota influence HPR.

The FLORA-ACS study will enroll 50 subjects with a history of ACS treated with ticagrelor (standard maintenance dose of 90 mg orally twice a day) and characterized by HPR. Participants will be enrolled in the study no sooner than 1 month and no later than 12 months following the ACS incident.

Platelet activity will be tested using the multiple electrode aggregometry method (Multiplate analyzer) with the HPR defined based on the consensus paper of the Working Group on On-Treatment Platelet Reactivity. Concurrently, fecal samples will be collected for microbiome profiling. The microbiota will be analyzed in terms of fecal bacterial richness and diversity using 16S ribosomal RNA sequencing.

Participants will receive a 7-day course of oral rifaximin (400 mg every 12 hours). Both platelet activity and microbiota testing will be conducted at baseline and post-treatment. Additional laboratory testing will include complete blood count and C-reactive protein. An analysis of major adverse cardiovascular events (MACE) occurrence within a 6-month follow-up period is planned.

Вмешательства

  • Препарат Rifaximin
    Participants receiving a 7-day course of oral rifaximin 400 mg every 12 hours

Первичные конечные точки

  • Change in platelet reactivity in Multiplate [Срок оценки: 0-7 days]
  • Achievement of platelet reactivity below HPR [Срок оценки: 0-7 days]
Вторичные конечные точки (5)
  • Relative reduction in platelet reactivity [Срок оценки: 0-7 days]
  • Achieving platelet reactivity below HPR in VerifyNow [Срок оценки: 0-7 days]
  • Relative reduction in platelet reactivity in thromboelastography [Срок оценки: 0-7 days]
  • Achieving platelet reactivity below HPR in thromboelastography [Срок оценки: 0-7 days]
  • Changes in microbiome profile [Срок оценки: 0-7 days]

Критерии участия

Критерии включения

  • Between 18 and 80 years of age
  • History of acute coronary syndrome no sooner than 1 month and no later than 12 months prior to study inclusion
  • Current treatment with ticagrelor (90 mg orally twice a day)
  • High platelet reactivity assessed with multiple electrode aggregometry method (AUC of >46 U)
  • Provision of informed consent prior to any study procedures

Критерии исключения

  • History of hypersensitivity to rifaximin or other rifamycin-derived agent
  • Ongoing treatment with rifamycins
  • Platelet count < 100×10\^9/L or > 450×10\^9/L
  • Treatment with antibiotics, probiotics, or glucocorticoids within 3 months prior to study inclusion
  • History of gastrointestinal diseases such as inflammatory bowel disease, bowel obstruction, or gastrointestinal tumor
  • Infection, including gastrointestinal infection, within a month prior to study inclusion
  • History of Clostridium difficile infection
  • Current use of specific medications (warfarin, glycoprotein IIb/IIIa inhibitors, immunosuppressants, bile acid sequestrants, antidiarrheal agents)
  • Impaired liver function classified as Child-Pugh class B or C
  • Hemodynamic instability
  • Pregnancy or breastfeeding
  • Patients considered by the investigator to be uncooperative

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Польша · 1 центр
  • Cardiology Department, Dr. A. Jurasz University Hospital — Bydgoszcz

Идентификаторы

NCT: NCT07203846 · FLORA-ACS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗