Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
NCT06649240

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

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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