Implementation of an Algorithm- and Multi-professional Team-supported Strategy to Improve Lipid Management of Patients With Atherosclerotic Cardiovascular Disease

Официальное название

Implementation of an Algorithm- and Multi-professional Team-supported Strategy to Improve Lipid Management of Patients With Atherosclerotic Cardiovascular Disease: OPTIMIZE ASCVD

Обзор

This is a randomized, controlled, collaborative, multicenter, pilot implementation science study evaluating the hypothesis that algorithm- and multi-professional team-supported lipid management reduces low density lipoprotein-cholesterol (LDL-C) compared with usual care in patients with atherosclerotic cardiovascular disease (ASCVD).

Подробное описание

OPTIMIZE-ASCVD is a randomized, controlled, collaborative, open-label, multicenter pilot implementation science study evaluating the hypothesis that algorithm- (Appendix A) and multi-professional team-supported lipid management reduces LDL-C compared with usual care in patients with ASCVD.

Approximately 100 participants will be randomized (1:1).

* Participant preference for injectable vs oral lipid therapy will be recorded at baseline. * Participants allocated to algorithm-and multi-professional team-supported lipid management will be evaluated by a physician and prescribed lipid therapy which aims to achieve LDL-C target without titration. Participants will be contacted by a pharmacist to provide education about the medication and support any access issues. * Participants allocated to usual care will be referred for management by their usual care provider who will receive a summary of guideline recommendations

The study will include decentralized clinical trial features including use of local, Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories for blood tests, use of data extracted from the electronic medical record (EMR), electronic collection of patient-reported outcomes (PRO) and remote conduct of study activities. As an open label study with both strategy groups receiving GDMT, no Data and Safety Monitoring Committee will be convened. Study leadership will monitor aggregate data during the trial and may modify the sample size and/or cap enrollment of subgroups to ensure consistency with design assumptions.

Вмешательства

• Другое Algorithm- and multi-professional team-supported lipid management
  Algorithm- and multi-professional team-supported lipid management
• Другое Guideline-directed lipid management by usual care provider
  Guideline-directed lipid management by usual care provider

Первичные конечные точки

• The between group difference in LDL-C percent change [Срок оценки: Baseline to 3 months]

Вторичные конечные точки (3)

• Between group difference [Срок оценки: Baseline to 1 and 6 months]
• Between group difference [Срок оценки: 1, 3 and 6 months]
• Between group difference [Срок оценки: 1, 3 and 6 months]

Критерии участия

Критерии включения

• Provided informed consent
• Age >18 years inclusive at screening
• Documented atherosclerotic vascular disease including:

• Coronary artery disease (prior revascularization, myocardial infarction, imaging evidence of coronary atherosclerosis)
• Peripheral artery disease (prior revascularization, amputation, ankle: brachial index (ABI) ≤ 0.90, imaging evidence of extra-coronary atherosclerosis)
• Carotid artery disease (prior endarterectomy or stenting of the extracranial carotid artery or imaging evidence of carotid atherosclerosis)
• Imaging evidence of atherosclerotic vascular disease in a non-coronary vascular bed (e.g. aorta, mesenteric, renal)
• LDL-C >70mg/dL

Критерии исключения

• Any reason that, in the opinion of the investigator, the patient would be unable to adhere to the protocol for the duration of the study (e.g. terminal diagnosis, metastatic cancer) or in whom participation might result in harm.
• Planned active titration of current lipid-lowering therapy
• Myocardial infarction or arterial revascularization within prior 30 days

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

США · 1 центр

• University of Colorado Health System (UCHealth) — Aurora

Идентификаторы

NCT: NCT07334834 · 202401CPC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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