SVO70 (Optimal Target Low‐Density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke): Rationale and Study Design

Background Current stroke guidelines lack subtype‐specific recommendations for optimal low‐density lipoprotein cholesterol targets. Indeed, most lipid‐lowering trials have not differentiated between stroke subtypes or focused primarily on large artery atherosclerosis, leaving a gap in evidence for other stroke subtypes, such as small vessel occlusion stroke. This study is designed to evaluate whether intensive lipid‐lowering therapy is superior to standard therapy in reducing major adverse cardiovascular events among patients with small vessel occlusion stroke. Methods SVO70 (Optimal Target Low‐Density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke) is a multicenter, prospective, randomized, open, blinded‐end point clinical trial in which adult patients with neuroimaging‐confirmed small vessel occlusion stroke within 180 days of randomization will be enrolled. Key exclusion criteria include predefined low‐density lipoprotein cholesterol targets for other comorbidities, contraindications to statin, and pregnancy or lactation. Eligible participants will be randomized 1:1 to achieve low‐density lipoprotein cholesterol <70 mg/dL (intensive group) or 90 to 110 mg/dL (standard group). The trial aims to enroll 4016 participants over a 2‐year recruitment period, with a minimum follow‐up of 4 years. The primary end point is the occurrence of major adverse cardiovascular events, defined as cardiovascular death, stroke, and acute coronary syndrome, during the follow‐up period. Secondary end points include (1) any stroke, (2) ischemic stroke or transient ischemic attack, (3) hemorrhagic stroke, (4) cardiovascular death, (5) myocardial infarction, (6) all‐cause death, and (7) acute coronary syndrome. Conclusions This study will provide valuable information for determining optimal low‐density lipoprotein cholesterol targets for patients with small vessel occlusion stroke. Registration URL: https://ClinicalTrials.gov ; Unique Identifier: NCT06649240, Clinical Research Information Service (KCT0009043).