Меню
Идёт набор NCT05325034

Guideline Oriented Approach To Lipid Lowering In Asia-Pacific

Без фазы С лечением Cardiovascular Diseases Acute Coronary Syndrome Atherosclerosis Hypercholesterolemia

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: Early Intervention.
Кому может быть актуально
Состояния в реестре: Cardiovascular Diseases, Acute Coronary Syndrome, Atherosclerosis, Hypercholesterolemia. 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
Австралия, Китай, Индия, Япония, Малайзия +4
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Guideline Oriented Approach To Lipid Lowering In Asia-Pacific (GOAL-ASIA)

Обзор

Multinational, patient-level randomised, multi-phase standard-of-care control arm, parallel group, implementation study. Patients will be recruited during hospitalisation and be randomised to a multifaceted intervention to be delivered either 'early' (baseline) or 'late' (6 months), in a 1:1 fashion.

Подробное описание

The study will be conducted over two phases.

In phase I (0-6 months), participants randomized to 'early' will receive the intervention at baseline through 6 months, while those randomized to 'late' will receive standard-of-care and represent a control arm over this period.

In phase II (6 to 12 months), those randomized to 'late' will receive the intervention at 6 months, while the 'early' group will continue in follow-up.

Multifaceted Intervention The intervention aims to increase the likelihood of effecting guideline-directed change in lipid lowering therapy through two key actors - both the patient and their clinician(s). The intervention is deliberately nested within routine clinical care to enhance the generalisability of the findings beyond a research environment and to reflect other elements of real world practice.

* Patient-and-clinician 'Cholesterol score card'. This passport-sized document will serve as a communication, engagement and activation tool for patients. It will be provided to participants at the commencement of the intervention and filled out at each study follow up visit. Participants will be encouraged to fill out sections at clinically-driven follow up appointments with their treating clinicians (e.g. general practitioner, cardiologist). The Score Card documents four key fields to be completed by the participant, study team and participant's regular clinician including 1) 'current' LDL-C level, 2) participant's level of adherence to lipid-lowering therapy using modified Voil's criteria, 3) lipid-lowering management decisions made at the clinician's appointment and 4) currently prescribed lipid-lowering therapies. * Risk stratification for recurrent events. As part of the intervention, each participant will have their SMART Risk score of a recurrent event assessed using the 'U-prevent' online calculator. In addition, each participant's Lp(a) will be measured and presented graphically on a continuum of risk. Both of these risk assessments will be sent to the treating primary care clinician and a copy provided to the participant.

Standard of care Participants allocated to 'late' will receive standard-of-care for the first 6 months which involves the provision of the participant's lipid profile to their nominated primary care physician/general practitioner at 6 weeks, 3 months and 6 months.

Вмешательства

  • Поведенческое Early Intervention
    Participant and clinician lipid score card to increase the likelihood of effecting guideline-directed change in lipid lowering therapy through two key actors - both the patient and their clinician(s). The Score Card documents four key fields to be completed by the participant, study team and participant's regular clinician including 1) 'current' LDL-C level, 2) participant's level of adherence to lipid-lowering therapy using modified Voil's criteria, 3) lipid-lowering management decisions made

Первичные конечные точки

  • Proportion of patients achieving an LDL <1.4mmol/L [Срок оценки: 6 months]
Вторичные конечные точки (6)
  • Proportion of patients who undergo intensification of lipid-lowering therapy [Срок оценки: 6 months]
  • Proportion of patients prescribed high-intensity statin [Срок оценки: 6 months]
  • Proportion of patients prescribed high-intensity statin at 6 months [Срок оценки: 6 months]
  • Adherence to lipid lowering therapy [Срок оценки: 6 months]
  • Patient activation and engagement in care [Срок оценки: 6 months]
  • Proportion of patients achieving LDL<1.4mmol/L at 12 months [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • 18 years of age
  • Admission for Type I myocardial infarction

Критерии исключения

  • LDL <1.4mmol/L at baseline
  • Unable to provide contact details of primary care physician/general practitioner
  • Unable to provide written informed consent.
  • Unlikely to survive >12 months

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
Лечение

Центры проведения

Австралия · 5 центров
  • Illawarra Shoalhaven Local Health District — Wollongong
  • Cairns & Hinterland Hospital & Health Service — Cairns
  • Flinders Medical Centre — Bedford Park
  • Monash Health — Clayton
  • Western Health — Melbourne
Япония · 4 центра
  • Fukuoka University Hospital — Fukuoka
  • Kyorin University Hospital — Mitaka
  • National Cerebral and Cardiovascular Center — Osaka
  • Osaka Medical and Pharmaceutical University Hospital — Osaka
Малайзия · 3 центра
  • University Teknologi MARA, Hospital UiTM, UiTM Medical Centre — Shah Alam
  • National Heart Institute — Kuala Lumpur
  • University of Malaysia Medical Centre — Kuala Lumpur
Таиланд · 3 центра
  • Siriraj Hospital — Bangkok
  • Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast — Khon Kaen
  • Songklanagarind Hospital — Songkhla
Сингапур · 2 центра
  • National Heart Centre — Singapore
  • National University Hospital Singapore (NUHS) — Singapore
South Korea · 2 центра
  • PyeongChon Hallym University Sacred Heart Hospital — Pyeongchon
  • Kangnam Hallym University Sacred Heart Hospital — Seoul
Китай · 1 центр
  • Affiliated Zhongshan Hospital of Dalian University — Dalian
Индия · 1 центр
  • All India Institute of Medical Sciences — New Delhi
Тайвань · 1 центр
  • National Cheng Kung University Hospital — Tainan

Идентификаторы

NCT: NCT05325034 · APCMC-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗