Идёт набор NCT07157774

Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)

Фаза III С лечением Elevated Lp(a) Atherosclerotic Cardiovascular Disease (ASCVD)

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: Muvalaplin, Placebo.
Кому может быть актуально: Состояния в реестре: Elevated Lp(a), Atherosclerotic Cardiovascular Disease (ASCVD). 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: США, Аргентина, Австралия, Австрия, Бельгия +23
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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Muvalaplin on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) Who Have Had a Prior Atherosclerotic Cardiovascular Event or Are at Risk for a First Atherosclerotic Cardiovascular Event

Обзор

The purpose of this study is to evaluate the efficacy of muvalaplin in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke.

Вмешательства

Препарат Muvalaplin
Administered orally
Препарат Placebo
Administered orally

Первичные конечные точки

Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint [Срок оценки: Baseline up to End of Study (About 5.25 Years)]

Вторичные конечные точки (9)

Percent Change from Baseline in Lipoprotein(a) (Lp(a)) at Week 4 [Срок оценки: Baseline, Week 4]
Time to First Occurrence of Any Component of the MACE-3 Composite Endpoint [Срок оценки: Baseline up to End of Study (About 5.25 Years)]
Time to First Occurrence of Any Component of the Modified MACE-3 Composite Endpoint [Срок оценки: Baseline up to End of Study (About 5.25 Years)]
Time to First Occurrence of Any Component of the Coronary MACE-3 Composite Endpoint [Срок оценки: Baseline up to End of Study (About 5.25 Years)]
Time to First Occurrence of Any Component of MACE-3 + Major Adverse Limb Event (MALE) Composite Endpoint [Срок оценки: Baseline up to End of Study (About 5.25 Years)]
Time to Occurrence of All-Cause Mortality [Срок оценки: Baseline up to End of Study (About 5.25 Years)]
Time to First Occurrence of Each Individual Component of the MACE-4 Composite Endpoint [Срок оценки: Baseline up to End of Study (About 5.25 Years)]
Change from Baseline to Each Annual Visit for Health-Care Resource Utilization (HCRU) [Срок оценки: Baseline up to End of Study (About 5.25 Years)]
Pharmacokinetics (PK): Trough Concentration at Steady State (C-trough, ss) of Muvalaplin [Срок оценки: Predose through Week 96]

Критерии участия

Критерии включения

Have Lp(a) ≥175 nanomoles per liter (nmol/L)
Meet one of the following criteria:

Have had a prior atherosclerotic cardiovascular disease (ASCVD) event (such as heart attack, stroke, or procedure to restore blood flow to the heart or other parts of the body) within 10 years prior to screening
Are at risk for a first ASCVD event, defined as one or more of the following:

Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without a history of ASCVD event
A high coronary artery calcium (CAC) score
Reduced kidney function with diabetes
Combination(s) of high risk factors

Критерии исключения

Have experienced a major cardiovascular event or surgery, such as heart attack, stroke, or procedure to restore blood flow to the heart or other parts of the body, within 90 days prior to screening or occurring between screening and randomization
Are planning or expected to undergo a procedure to restore blood flow in the arteries or a major heart surgery during the study
Have uncontrolled high blood pressure
Have New York Heart Association (NYHA) class III or IV heart failure
Have undergone a procedure to remove cholesterol from the blood within 90 days of screening, or have a planned procedure during the study
Have severe kidney impairment
Have had cancer within 5 years prior to screening

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: Двойное слепое
Основная цель: Лечение