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Идёт набор NCT06804980

DESIFOR-EXPAND (MHIF)

Фаза IV С лечением Statin Therapy Statin Adverse Reaction Statin

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: Rosuvastatin (Crestor), Placebo.
Кому может быть актуально
Состояния в реестре: Statin Therapy, Statin Adverse Reaction, Statin. Базовые параметры: от 21 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The DEterminig Statin Intolerance for Rosuvastatin Trial

Обзор

The DESIFOR pilot study was conducted to determine the feasibility of utilizing an n-of-1 trial to facilitate tolerance of unblinded rosuvastatin in patients with prior statin intolerance

Подробное описание

Recently developed lipid lowering therapies have been shown to significantly reduce LDL cholesterol and subsequent CVD risk (1, 2). However, they are expensive, and the cost-effectiveness of these medications remains controversial, especially in primary prevention. Novel lipid lowering therapies are frequently considered for individuals with statin intolerance, but payers frequently deny prescription for these medications due to lack of adequate proof of true statin intolerance. How to accurately determine statin intolerance remains a clinical conundrum for both patients and providers. A more scientific, definitive method to determine statin intolerance could potentially allow appropriate, cost-effective use of statin therapy in individuals found to not actually be statin intolerant as well as judicious use of novel medications in patients who are found to truly be statin intolerant.

The DESIFOR pilot study was conducted to determine the feasibility of utilizing an n-of-1 trial to facilitate tolerance of unblinded rosuvastatin in patients with prior statin intolerance. The DESIFOR pilot study was a single-center, randomized, double-blinded, n-of-1 trial in patients aged 21 to 79 years and eligible for statin therapy by current guidelines but not on therapy due to intolerance of \>2 statins. Using a double-blinded, N-of-1 randomized trial in patients with previous statin intolerance, \<10% of patients had data suggestive of true statin intolerance, and 2/3 of patients were subsequently able to tolerate 3-months of unblinded treatment with rosuvastatin (3). These data raise the hypothesis that an n-of-1 trial can be used to facilitate tolerance of unblinded rosuvastatin in patients with prior statin intolerance.

Вмешательства

  • Препарат Rosuvastatin (Crestor)
    The patient will take 3 28-day packs of placebo and 2 28-day packs of rosuvastatin. The order in which they take the placebo or rosuvastatin will be assigned at random.
  • Препарат Placebo
    The patient will take 3 28-day packs of placebo and 2 28-day packs of rosuvastatin. The order in which they take the placebo or rosuvastatin will be assigned at random.

Первичные конечные точки

  • Musculoskeletal symptom presence/absence [Срок оценки: 9 months]
  • Statin Tolerance [Срок оценки: 9 months]
  • Variables associated with statin intolerance [Срок оценки: 9 months]

Критерии участия

Критерии включения

  • Adult patients (≥ 21 years old) with a prior history of statin intolerance. Statin intolerance is defined by discontinuation of at least 2 different statin medications due to possible side effects. Patients can participate in the trial while on other lipid-lowering agents, such as ezetimibe and PSCK9 inhibitors, as long as the patient has been on the other lipid lowering therapy and tolerating it well for at least 1 month. For individuals with established ASCVD or multiple ASCVD risk factors, initiation of other lipid lowering therapy prior to participation in DESIFOR is encouraged.
  • 2\. At least 30 days since discontinued use of a statin

Критерии исключения

  • Women who are pregnant, nursing or attempting to become pregnant
  • Individuals who experienced severe reactions in the past, including rhabdomyolysis, severe myositis, anaphylaxis
  • Individuals who are not otherwise clinically indicated to take rosuvastatin 20 mg

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Одна группа
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Minneapolis Heart Institute Foundation — Minneapolis

Идентификаторы

NCT: NCT06804980 · 2236054

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗