Optimal Target Low-density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke (SVO70)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,016
- 试验地点
- 92
- 主要终点
- Major adverse cardiovascular event
研究概览
简要总结
Lipid-lowering therapy constitutes a cornerstone of secondary prevention in ischemic stroke; however, current stroke guidelines remain deficient in providing optimal target low-density lipoprotein (LDL)-cholesterol levels tailored to the stroke subtypes. Most clinical trials on LDL-cholesterol management have not differentiated between stroke subtypes or have primarily focused on large artery atherosclerosis (LAA) stroke, leaving a gap in evidence for managing LDL-cholesterol in other stroke subtypes, e.g., small vessel occlusion (SVO) stroke. While hypertension is the leading risk factor for SVO strokes, the link between elevated LDL-cholesterol and SVO stroke is also recognized. Establishing optimal LDL-cholesterol targets for SVO stroke would significantly enhance secondary prevention strategies and improve patient outcome. Thus, the investigators aim to compare intensive versus standard lipid-lowering in patients with SVO stroke. SVO70 is a multicenter, prospective, randomized, open, blinded-endpoint clinical trial. Adult participants with objectively confirmed SVO stroke within 180 days of randomization will be included. Exclusion criteria include those with predefined LDL-cholesterol targets for other conditions, baseline LDL-cholesterol <70 mg/dL in the absence of lipid-lowering therapy, statin contraindications, or women who are pregnant, breastfeeding, or planning pregnancy during the study period. Eligible participants will be randomized 1:1 to target LDL-cholesterol <70 mg/dL (intensive group) or 90-110 mg/dL (standard group). The trial plans to enroll 4,016 participants, with the primary outcome being major adverse cardiovascular events-cardiovascular death, stroke, and acute coronary syndrome-during a follow-up period of at least 4 years. This study would provide valuable information for determining the optimal LDL-cholesterol target for patients with SVO stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Prospective, Randomized, Open-label, Blinded Endpoint (PROBE) trial
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 years or older
- •Patients with objectively confirmed small vessel occlusive infarctions in the subcortical or brainstem regions, identified through neuroimaging (MRI or CT)
- •Patients with a history of symptomatic ischemic stroke caused by the lesion described in 2), occurring within 180 days prior to enrollment
- •Patients or guardians who agree to the study protocol and sign with informed consent
排除标准
- •Extracranial or intracranial large artery stenosis ≥50%
- •History of atherosclerotic ischemic stroke or transient ischemic attack
- •Documented coronary artery disease
- •Documented peripheral artery disease or aortic atherosclerotic disease
- •Diabetes with one or more of the following: duration ≥10 years; ≥2 major risk factors (men ≥45 years, women ≥55 years; family history of premature atherosclerotic cardiovascular disease; hypertension; current smoking; or HDL cholesterol <40 mg/dL); or known evidence of target organ damage (albuminuria, estimated glomerular filtration rate <60 mL/min per 1.73 m², retinopathy, neuropathy, or left ventricular hypertrophy)
- •Baseline LDL cholesterol <70 mg/dL in the absence of lipid-lowering therapy (statins, ezetimibe, PCSK9 inhibitors, etc.)
- •Patients contraindicated for statin use (e.g., active liver disease, serum transaminase levels elevated more than three times the normal limit, muscle disorders, hypersensitivity to statins, or taking medications contraindicated for use with statins)
- •Women who are pregnant, breastfeeding, or intending to become pregnant during the study period
- •Deemed unsuitable for participation in the study for more than four years, as per the investigators' discretion
研究组 & 干预措施
Intensive group
Target LDL-cholesterol <70 mg/dL
干预措施: PCSK9 inhibitor (Drug)
Intensive group
Target LDL-cholesterol <70 mg/dL
干预措施: Statins and/or Ezetimibe (Drug)
Standard group
Target LDL-cholesterol 90-110 mg/dL
干预措施: Statins and/or Ezetimibe (Drug)
Standard group
Target LDL-cholesterol 90-110 mg/dL
干预措施: PCSK9 inhibitor (Drug)
结局指标
主要结局
Major adverse cardiovascular event
时间窗: 4 years
Major adverse cardiovascular event (MACE) includes cardiovascular death, stroke, and acute coronoary syndrome (i.e., ST-elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina).
次要结局
- Any death(4 years)
- Cardiovascular death(4 years)
- Myocardial infarction(4 years)
- Any stroke(4 years)
- Ischemic stroke or transient ischemic attack(4 years)
- Acute coronary syndrome(4 years)
- Hemorrhagic stroke(4 years)
研究者
Seung-Hoon Lee
Professor
Seoul National University Hospital