Actively Recruiting
Optimal Target Low-density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke
Led by Seoul National University Hospital · Updated on 2025-05-21
4016
Participants Needed
46
Research Sites
308 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Hospital
Lead Sponsor
H
Hanmi Pharmaceutical co., ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Optimal Target Low-density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Confirmed small vessel occlusive stroke in subcortical or brainstem regions by MRI or CT
- Stroke occurred within 180 days before enrollment
- Patient or guardian agrees to study protocol and provides informed consent
You will not qualify if you...
- Need for intensive LDL cholesterol management below 70 mg/dL due to another condition
- Contraindication to statins (such as active liver disease, very high liver enzymes, muscle disorders, statin allergies, or conflicting medications)
- Women who are pregnant, breastfeeding, or plan pregnancy during the study period
- Considered unsuitable for participation over more than four years by investigators
AI-Screening
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Trial Site Locations
Total: 46 locations
1
Korea University Ansan Hospital
Ansan, South Korea
Actively Recruiting
2
Hallym University Sacred Heart Hospital
Anyang, South Korea
Actively Recruiting
3
Pusan National University Hospital
Busan, South Korea
Actively Recruiting
4
Gyeongsang National University Changwon Hospital
Changwon, South Korea
Actively Recruiting
5
Samsung Changwon Hospital
Changwon, South Korea
Actively Recruiting
6
Chungbuk National University Hospital
Cheongju-si, South Korea
Actively Recruiting
7
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, South Korea
Actively Recruiting
8
Kangwon National University Hospital
Chuncheon, South Korea
Actively Recruiting
9
Daegu Catholic University Medical Center
Daegu, South Korea
Actively Recruiting
10
Keimyung University Dongsan Medical Center
Daegu, South Korea
Actively Recruiting
11
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Actively Recruiting
12
Kyungpook National University Hospital
Daegu, South Korea
Actively Recruiting
13
Chungnam National University Hospital
Daejeon, South Korea
Actively Recruiting
14
Daejeon Eulji Medical Center
Daejeon, South Korea
Actively Recruiting
15
Dongguk University Ilsan Hospital
Goyang, South Korea
Actively Recruiting
16
Ilsan Paik Hospital
Goyang, South Korea
Actively Recruiting
17
National Health Insurance Service Ilsan Hospital
Goyang, South Korea
Actively Recruiting
18
Hanyang University Guri Hospital
Guri-si, South Korea
Actively Recruiting
19
Chonnam National University Hospital
Gwangju, South Korea
Actively Recruiting
20
Chosun University Hospital
Gwangju, South Korea
Actively Recruiting
21
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, South Korea
Actively Recruiting
22
Dongtan Sacred Heart Hospital
Hwaseong, South Korea
Actively Recruiting
23
Wonkwang University Hospital
Iksan, South Korea
Actively Recruiting
24
Gachon University Gil Medical Center
Incheon, South Korea
Actively Recruiting
25
Inha University Hospital
Incheon, South Korea
Actively Recruiting
26
International St. Mary's Hospital
Incheon, South Korea
Actively Recruiting
27
Jeju National University Hospital
Jeju City, South Korea
Actively Recruiting
28
Seoul National University Bundang Hospital
Seongnam, South Korea
Actively Recruiting
29
Asan Medical Center
Seoul, South Korea
Not Yet Recruiting
30
Chung-Ang University Hospital
Seoul, South Korea
Actively Recruiting
31
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Actively Recruiting
32
Ewha Womans University Seoul Hospital
Seoul, South Korea
Actively Recruiting
33
Gangnam Severance Hospital
Seoul, South Korea
Actively Recruiting
34
Hallym University Kangdong Sacred Heart Hospital
Seoul, South Korea
Actively Recruiting
35
Hanyang University Seoul Hospital
Seoul, South Korea
Actively Recruiting
36
Konkuk University Medical Center
Seoul, South Korea
Actively Recruiting
37
Korea University Anam Hospital
Seoul, South Korea
Actively Recruiting
38
Kyung Hee University Medical Center
Seoul, South Korea
Actively Recruiting
39
National Medical Center
Seoul, South Korea
Actively Recruiting
40
Nowon Eulji Medical Center
Seoul, South Korea
Actively Recruiting
41
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
42
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Seoul, South Korea
Actively Recruiting
43
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
44
Severance Hospital
Seoul, South Korea
Actively Recruiting
45
Yeouido St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
46
Yongin Severance Hospital
Yŏngin, South Korea
Actively Recruiting
Research Team
W
Wookjin Yang, MD, PhD
CONTACT
S
Seung-Hoon Lee, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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