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Идёт набор NCT07034690

Study to Evaluate the Impact of a Targeted Lipid Optimization Program on LDL-C Control in At-risk Adult Patients With Dyslipidemia

Фаза IV С лечением Atherosclerotic Cardiovascular Disease

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: Educational Material, Standard of care.
Кому может быть актуально
Состояния в реестре: Atherosclerotic Cardiovascular Disease. 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
ОАЭ
Следующий шаг
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Официальное название

A Prospective, Type I Hybrid Effectiveness-implementation, Open Label, Randomized Study to Evaluate the Impact of a Targeted Lipid Optimization Program on LDL-C Control in at- Risk Adult Patients From Abu Dhabi, United Arab Emirates (UAE) With Dyslipidemia

Обзор

This study is an open label, randomized, prospective, type I hybrid effectiveness- implementation, pragmatic clinical trial to evaluate the impact of a targeted lipid optimization program on LDL-C control in participants with dyslipidemia who are at high risk or very high risk of cardiovascular events.

Подробное описание

The treatment of interest is a lipid optimization program in the form of a health education intervention delivered via clinic visits (every 4 months) and virtual sessions (between each clinic visit).

No active drug treatment will be provided. The intervention in this study will involve the implementation of a lipid optimization, education program for patients at high risk and very high risk of cardiovascular events.

Вмешательства

  • Другое Educational Material
    Health Education Intervention delivered via clinic visits (every 4 months) and virtual sessions (between each clinic visit)
  • Другое Standard of care
    Standard of care

Первичные конечные точки

  • Percentage of participants achieving target LDL-C goals based on CV risk [Срок оценки: Baseline, month 12]
Вторичные конечные точки (12)
  • Percentage of participants achieving or maintaining target LDL-C goals based on CV risk [Срок оценки: Baseline, month 24]
  • Change of LDL-C [Срок оценки: Baseline, month 12 and month 24]
  • Change in the proportion of participants receiving advanced lipid lowering therapies [Срок оценки: Month 12 and Month 24]
  • Proportion of participants from the intervention group who complete all visits [Срок оценки: 24 months]
  • Proportion of participants from the intervention group who discontinue the education program [Срок оценки: 12 months]
  • Proportion of days covered [Срок оценки: Baseline, month 12 and month 24]
  • Number of hospitalizations [Срок оценки: 24 months]
  • Number of outpatient visits [Срок оценки: 24 months]
  • Number of ER visits [Срок оценки: 24 months]
  • Associated costs [Срок оценки: 24 months]
  • Number of LDL-C tests performed [Срок оценки: 24 months]
  • Change in knowledge awareness scores: [Срок оценки: Baseline, month 12 and month 24]

Критерии участия

Критерии включения

  • Diagnosis of ASCVD (coronary heart disease, peripheral arterial disease and/or cerebrovascular disease)
  • High risk or very high risk for cardiovascular events (as per the 2019 ESC/EAS guidelines \[1\] for the management of dyslipidemias)
  • Lipid levels:
  • High risk: LDL-C ≥70 mg/dl (or > 1.8 mmol/L) or non-HDL-C ≥100 mg/dl
  • Very high risk: LDL-C ≥55 mg/dl (or > 1.4 mmol/L) or non-HDL-C ≥85 mg/dl
  • Male or Female
  • 18 years or older
  • Seen by a specialist who is prescribing advanced lipid lowering treatments (LLTs) (cardiologist, endocrinologist or any other relevant specialist)
  • Currently taking maximum-tolerated statins
  • Ability to participate in educational program (must be able to watch online videos)
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Критерии исключения

  • Any surgical or medical condition, which in the opinion of the Investigator, may place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study.
  • Unwillingness or inability (e.g., physical or cognitive) to comply with study procedures (including adherence to study visits).
  • Participation in any other interventional study.
  • Inability to travel to study sites for in-person clinic visits.
  • Responsible physician clinical decision not to engage the identified patient.
  • Refusal of the potential participant to sign the consent and be included in the model.

Other protocol-defined inclusion/exclusion criteria may apply

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
Открытое
Основная цель
Другое

Центры проведения

ОАЭ · 1 центр
  • Novartis Investigative Site — Abu Dhabi

Идентификаторы

NCT: NCT07034690 · CKJX839A1AE02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗