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Идёт набор NCT06874192

Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study

Фаза I С лечением Statin Adverse Reaction

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: Low-dose colchicine at 0.5mg daily, Placebo.
Кому может быть актуально
Состояния в реестре: Statin Adverse Reaction. 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
США
Следующий шаг
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Обзор

Statins are a class of cholesterol lowering medications that contribute to reducing a person's risk of experiencing a cardiovascular event like heart attack. Along with the ability to lower cholesterol, statins also possess anti-inflammatory properties which contribute to their cardioprotective effects. Some people experience side effects while taking statins and are unable to continue treatment with them,which can then increase a person's risk of having cardiovascular issues due to untreated high cholesterol levels. Prior studies have shown that inflammation in the body may lead to an increased risk of a future cardiovascular events. Low dose colchicine (LODOCO), an anti-inflammatory agent, has been shown to reduce cardiovascular events by inhibiting inflammation, a major cause of cardiovascular disease. The United States Food and Drug Administration (FDA) has approved LODOCO to reduce the risk of a future cardiac events for those who have existing heart disease or possess multiple risk factors for heart disease.

Подробное описание

This study will test the effects of LODOCO in those who have previously been identified as statin intolerant, meaning they are unable to continue taking statins because of side effects. The primary objective of this study is to evaluate the safety and efficacy of low-dose colchicine (LODOCO) in subjects with statin intolerance. Safety will be assessed by monitoring the incidence of adverse events from baseline to four weeks. Efficacy will be determined by measuring the change in high-sensitivity C-reactive protein (hs-CRP) levels from baseline to four weeks..

Вмешательства

  • Препарат Low-dose colchicine at 0.5mg daily
    LODOCO is low-dose colchicine at 0.5mg daily, ii is an FDA approved anti-inflammatory drug, to prevent cardiovascular events in patients with coronary artery disease. LODOCO works by inhibiting microtubule formation and reducing the activity of neutrophils, which play a key role in inflammation.
  • Другое Placebo
    Matching placebo

Первичные конечные точки

  • Safety will be assessed by monitoring the incidence of adverse events [Срок оценки: Baseline to four weeks.]
  • Efficacy will be determined by measuring the change in high-sensitivity C-reactive protein [Срок оценки: Baseline to four weeks]
Вторичные конечные точки (2)
  • To investigate the changes in interleukin-6 (IL-6) levels with low-dose colchicine therapy in patients with statin intolerance. [Срок оценки: baseline to four weeks]
  • To assess changes in lipid profile from baseline to 30 days [Срок оценки: baseline to four weeks.]

Критерии участия

Критерии включения

  • History of statin intolerance (As defined by the NLA 2023 guidelines) Patients who have experienced one or more adverse effects associated with statin therapy, which resolves or improves with dose continuation or reduction
  • Stable dose of lipid-lowering regimen (statin or non-statin) for at least one month
  • Patients able to provide informed consent.
  • Aged 18 to 80 will be enrolled in the study.

Критерии исключения

  • Known hypersensitivity to colchicine, current use of colchicine or other anti-inflammatory medications.
  • Renal impairment (eGFR <45 mL/min/1.73 m2)
  • Transaminitis (ALT or AST >3 times upper limit of normal)
  • Cirrhosis
  • Severe Heart Failure
  • Active cancer or currently on chemotherapy
  • Irritable Bowel Syndrome, Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis) or other diarrheal related GI pathologies
  • Active infection
  • Autoimmune or inflammatory condition
  • Pregnancy or breastfeeding.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Virginia Commonwealth University — Richmond

Идентификаторы

NCT: NCT06874192 · HM20030934

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗