Идёт набор NCT06501443

LATAM LOWERS LDL-C

Фаза IV С лечением Hypercholesterolaemia

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: Usual care, KJX839.
Кому может быть актуально: Состояния в реестре: Hypercholesterolaemia. Базовые параметры: 18 лет — 100 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: Аргентина, Бразилия
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

Latin America Lipid Optimization After Acute Event in Patients With AthErosclerotic CardiovasculaR DiseaSe and High LDL-C

Обзор

This is an open label, patient-level 1:1 randomized clinical trial in a multi-country study aiming to evaluate the real-world impact of inclisiran + Usual Care (UC) vs UC alone on LDL-C lowering, patient-reported outcomes, and healthcare resource utilization in an in-hospital population of patients, admitted during the acute setting, stabilized and before discharge, following an acute cardiovascular event.

Подробное описание

The primary objective is to evaluate the impact of inclisiran plus usual care on LDL-C lowering versus usual care after acute MI, confirmed ischemic stroke, or urgent coronary revascularization.

The secondary objective is to compare the LDL-C reduction of both arms in target population.

Study completion for an individual participant is defined as when the participant finishes the last visit (day 330) and any assessments associated with that visit.

Вмешательства

Препарат Usual care
Treatment after acute event approved in the country where patient is based. It may include educational intervention according to each country guidelines
Препарат KJX839
Inclisiran in solution for subcutaneous injection on day 1, day 90, and day 270

Первичные конечные точки

Change in LDL-C from baseline to 330 days [Срок оценки: Baseline and Day 330]

Вторичные конечные точки (4)

Proportion of patients with >=50% reduction in LDL-C from baseline. [Срок оценки: Baseline and Day 330]
Proportion of patients achieving LDL-C goal of <70 mg/dL [Срок оценки: Baseline and Day 330]
Among participants with a baseline LDL-C≥55 mg/dL: Proportion of patients achieving LDL-C goal of <55 mg/dL [Срок оценки: Baseline and Day 330]
Number of participants by timing of statin initiation [Срок оценки: Up to 330 days]

Критерии участия

Критерии включения

Admitted for MI (Type 1 NSTEMI or STEMI), urgent (i.e., non-elective) coronary revascularization (PCI or CABG) or confirmed ischemic stroke.
Stable patient: Patient will be considered stable if they did not suffer cardiac arrest at presentation or if in the last 24 hours before randomization:

Was not in cardiogenic shock.
Did not required invasive hemodynamic, inotropic or vasopressor support.
Participants are required to be eligible for receiving inclisiran in accordance to approved local label.

Of note, patients who are initiated on statin therapy during the same hospitalization will not be excluded, as we expect a proportion of patients at baseline to not yet be on statin therapy in this real-world study. This will enhance the generalizability and pragmatic aspects of the study. However, because initiation of statin therapy at or near the time of enrollment could impact the primary outcome (if there is imbalance between the arms, or if there is differential stopping of statin therapy between the arms), we will stratify randomization by this factor and will pre-specify analyses in those who have vs. have not been initiated on statin therapy during the same hospitalization.

Критерии исключения

Currently on PCSK9i therapy (within last 3 months)
Current participation in another clinical study with another study drug
Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Baseline Visit
Pregnant or nursing (lactating) women
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception

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

Здоровые добровольцы: Нет