Cholesterol Optimization After Stroke: a Multicenter Prospective Study on LDL Cholesterol Control in Patients With Acute Stroke.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- Adherence to lipid-lowering therapy
研究概览
简要总结
This study (acronym COAST Trial) is a multicenter observational registry aiming to document: patients' adherence and persistence to lipid-lowering therapy prescribed for secondary prevention; the proportion of patients achieving LDL cholesterol therapeutic targets at 3 months; the incidence of cerebrovascular recurrence and mortality at 90 days, as well as the occurrence of any adverse effects from these therapies. This information will provide a snapshot of post-stroke/TIA lipid-lowering management across centers and identify areas for improvement, offering useful data to optimize secondary prevention strategies in everyday clinical practice.
详细描述
SYNOPSIS STUDY TITLE COAST Study - Cholesterol Optimization After Stroke: a multicenter prospective study on LDL cholesterol control in patients with acute stroke.
ACRONYM COAST (COAST - Cholesterol Optimization After Stroke Trial: a multicenter prospective study on LDL cholesterol control in patients with acute stroke) SPONSOR Agostino Gemelli University Hospital Foundation IRCCS L.go Francesco Vito 1, 00168 Rome CRO N/A CO-FUNDER N/A PRINCIPAL INVESTIGATOR Dr. Giovanni Frisullo Head, UOSD Emergency Neurology BACKGROUND AND RATIONALE OF THE STUDY Stroke is the leading cause of disability and among the main causes of mortality worldwide. A significant proportion of patients with stroke have large-vessel atherosclerosis or other vascular risk factors; therefore, aggressive management of plasma lipids is crucial for secondary prevention. In routine clinical practice, the assessment of the lipid profile and the control of hypercholesterolemia are extremely variable, encompassing low-fat diets, various supplements, or medications. In light of these considerations, a prospective real-life study is needed to evaluate how patients with ischemic stroke, hemorrhagic stroke, or TIA are managed regarding lipid profile assessment and LDL-C control in secondary prevention. This study (acronym COAST Trial) is a multicenter observational registry aiming to document: patients' adherence and persistence to lipid-lowering therapy prescribed for secondary prevention; the proportion of patients achieving LDL cholesterol therapeutic targets at 3 months; the incidence of cerebrovascular recurrence and mortality at 90 days, as well as the occurrence of any adverse effects from these therapies. This information will provide a snapshot of post-stroke/TIA lipid-lowering management across centers and identify areas for improvement, offering useful data to optimize secondary prevention strategies in everyday clinical practice.
STUDY OBJECTIVES
Primary:
To assess patients' adherence and persistence to lipid-lowering therapy prescribed for secondary prevention (low-fat diet, supplements, statins, ezetimibe, bempedoic acid, PCSK9 inhibitors, fibrates, or other lipid-lowering agents) 3 months after the acute cerebrovascular event (ischemic stroke, intracerebral hemorrhage, or TIA).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Recent acute cerebrovascular event, defined as a confirmed diagnosis of ischemic stroke, hemorrhagic stroke, or TIA occurring less than 30 days prior to enrollment.
- •Availability of a baseline measured LDL cholesterol value (direct or calculated) at the time of the index event or close to it.
- •Patients for whom, in routine clinical practice, a lipid-lowering therapy has been indicated and prescribed for secondary prevention (low-fat diet, supplements, statins, ezetimibe, bempedoic acid, PCSK9 inhibitors, fibrates, or other lipid-lowering agents).
- •Written informed consent obtained and signed by the patient before inclusion. If the patient is unable to provide consent autonomously (e.g., due to aphasia, impaired consciousness, etc.), informed consent will be obtained from a legal representative or proxy, in accordance with applicable regulations.
排除标准
- •• Comorbidities or conditions preventing 3-month follow-up: e.g., terminal oncological disease with life expectancy <3 months, severe cognitive impairment (e.g., advanced dementia), or other conditions that make it impossible to obtain follow-up information; inability to contact the patient after discharge (e.g., non-resident foreign patient or lacking telephone contacts).
- •Any other clinical, psychological, or social condition that, in the investigator's judgment, may compromise the patient's ability to adhere to the study or the reliability of the collected data.
结局指标
主要结局
Adherence to lipid-lowering therapy
时间窗: 3 months
Adherence to lipid-lowering therapy, defined as the percentage of patients who are adherent (intake of ≥80% of prescribed doses) and persistent (on therapy without interruptions) at the end of follow-up. Rates of persistence (patients who did not discontinue therapy) and adherence (patients who took it regularly) may also be considered separately.
次要结局
- Proportion of patients achieving an LDL target value(3 months)
- Recurrence of stroke (ischemic or hemorrhagic), TIA, or acute cardiovascular events(3 months)
- All-cause mortality(3 months)
- Adverse events related to lipid-lowering medications(3 months)
- Functional disability(3 months)
研究者
Frisullo Giovanni
MD, PhD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS