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RECRUITING
NCT06649240
NA

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

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

Summary

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, 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.

Official title: Optimal Target Low-density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke (SVO70)

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4016

Start Date

2024-10-04

Completion Date

2030-09

Last Updated

2025-05-21

Healthy Volunteers

No

Interventions

DRUG

Statins and/or Ezetimibe

Statin ± Ezetimibe to achieve target LDL-cholesterol level

DRUG

PCSK9 inhibitor

The use of PCSK9 inhibitors is permitted to achieve target LDL-cholesterol levels in participants who did not reach the target with statins ± ezetimibe.

Locations (46)

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