Optimal Target Low-density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke

Description

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.

Interventions

• Statins and/or Ezetimibe (Drug)
  Statin ± Ezetimibe to achieve target LDL-cholesterol level
• PCSK9 inhibitor (Drug)
  The use of PCSK9 inhibitors is permitted to achieve target LDL-cholesterol levels in participants who did not reach the target with statins ± ezetimibe.

Eligibility criteria

Conditions

Locations

• Korea University Ansan Hospital — Ansan, South Korea
• Hallym University Sacred Heart Hospital — Anyang, South Korea
• Pusan National University Hospital — Busan, South Korea
• Gyeongsang National University Changwon Hospital — Changwon, South Korea
• Samsung Changwon Hospital — Changwon, South Korea
• Chungbuk National University Hospital — Cheongju-si, South Korea
• Hallym University Chuncheon Sacred Heart Hospital — Chuncheon, South Korea
• Kangwon National University Hospital — Chuncheon, South Korea
• Daegu Catholic University Medical Center — Daegu, South Korea
• Keimyung University Dongsan Medical Center — Daegu, South Korea
• Kyungpook National University Chilgok Hospital — Daegu, South Korea
• Kyungpook National University Hospital — Daegu, South Korea
• Chungnam National University Hospital — Daejeon, South Korea
• Daejeon Eulji Medical Center — Daejeon, South Korea
• Dongguk University Ilsan Hospital — Goyang, South Korea
• Ilsan Paik Hospital — Goyang, South Korea
• National Health Insurance Service Ilsan Hospital — Goyang, South Korea
• Hanyang University Guri Hospital — Guri-si, South Korea
• Chonnam National University Hospital — Gwangju, South Korea
• Chosun University Hospital — Gwangju, South Korea
• Chung-Ang University Gwangmyeong Hospital — Gwangmyeong, South Korea
• Dongtan Sacred Heart Hospital — Hwaseong, South Korea
• Wonkwang University Hospital — Iksan, South Korea
• Gachon University Gil Medical Center — Incheon, South Korea
• Inha University Hospital — Incheon, South Korea
• International St. Mary's Hospital — Incheon, South Korea
• Jeju National University Hospital — Jeju City, South Korea
• Seoul National University Bundang Hospital — Seongnam, South Korea
• Asan Medical Center — Seoul, South Korea
• Chung-Ang University Hospital — Seoul, South Korea
• Ewha Womans University Mokdong Hospital — Seoul, South Korea
• Ewha Womans University Seoul Hospital — Seoul, South Korea
• Gangnam Severance Hospital — Seoul, South Korea
• Hallym University Kangdong Sacred Heart Hospital — Seoul, South Korea
• Hanyang University Seoul Hospital — Seoul, South Korea
• Konkuk University Medical Center — Seoul, South Korea
• Korea University Anam Hospital — Seoul, South Korea
• Kyung Hee University Medical Center — Seoul, South Korea
• National Medical Center — Seoul, South Korea
• Nowon Eulji Medical Center — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea
• Seoul Metropolitan Government-Seoul National University Boramae Medical Center — Seoul, South Korea
• Seoul National University Hospital — Seoul, South Korea
• Severance Hospital — Seoul, South Korea
• Yeouido St. Mary's Hospital — Seoul, South Korea
• Yongin Severance Hospital — Yŏngin, South Korea