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

Status: Recruiting
Location: See all (46) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Age 19 years or older

• Patients with objectively confirmed small vessel occlusive infarctions in the subcortical or brainstem regions, identified through neuroimaging (MRI or CT)

• Patients with a history of symptomatic ischemic stroke caused by the lesion described in 2), occurring within 180 days prior to enrollment

• Patients or guardians who agree to the study protocol and sign with informed consent

Locations
Other Locations
Republic of Korea
Korea University Ansan Hospital
RECRUITING
Ansan
Hallym University Sacred Heart Hospital
RECRUITING
Anyang
Pusan National University Hospital
RECRUITING
Busan
Gyeongsang National University Changwon Hospital
RECRUITING
Changwon
Samsung Changwon Hospital
RECRUITING
Changwon
Chungbuk National University Hospital
RECRUITING
Cheongju-si
Hallym University Chuncheon Sacred Heart Hospital
RECRUITING
Chuncheon
Kangwon National University Hospital
RECRUITING
Chuncheon
Daegu Catholic University Medical Center
RECRUITING
Daegu
Keimyung University Dongsan Medical Center
RECRUITING
Daegu
Kyungpook National University Chilgok Hospital
RECRUITING
Daegu
Kyungpook National University Hospital
RECRUITING
Daegu
Chungnam National University Hospital
RECRUITING
Daejeon
Daejeon Eulji Medical Center
RECRUITING
Daejeon
Dongguk University Ilsan Hospital
RECRUITING
Goyang
Ilsan Paik Hospital
RECRUITING
Goyang
National Health Insurance Service Ilsan Hospital
RECRUITING
Goyang
Hanyang University Guri Hospital
RECRUITING
Guri-si
Chonnam National University Hospital
RECRUITING
Gwangju
Chosun University Hospital
RECRUITING
Gwangju
Chung-Ang University Gwangmyeong Hospital
RECRUITING
Gwangmyeong
Dongtan Sacred Heart Hospital
RECRUITING
Hwaseong
Wonkwang University Hospital
RECRUITING
Iksan
Gachon University Gil Medical Center
RECRUITING
Incheon
Inha University Hospital
RECRUITING
Incheon
International St. Mary's Hospital
RECRUITING
Incheon
Jeju National University Hospital
RECRUITING
Jeju City
Seoul National University Bundang Hospital
RECRUITING
Seongnam
Asan Medical Center
NOT_YET_RECRUITING
Seoul
Chung-Ang University Hospital
RECRUITING
Seoul
Ewha Womans University Mokdong Hospital
RECRUITING
Seoul
Ewha Womans University Seoul Hospital
RECRUITING
Seoul
Gangnam Severance Hospital
RECRUITING
Seoul
Hallym University Kangdong Sacred Heart Hospital
RECRUITING
Seoul
Hanyang University Seoul Hospital
RECRUITING
Seoul
Konkuk University Medical Center
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Kyung Hee University Medical Center
RECRUITING
Seoul
National Medical Center
RECRUITING
Seoul
Nowon Eulji Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
Yeouido St. Mary's Hospital
RECRUITING
Seoul
Yongin Severance Hospital
RECRUITING
Yŏngin
Contact Information
Primary
Wookjin Yang, MD, PhD
ywj_2002@naver.com
+82-70-4352-2482
Backup
Seung-Hoon Lee, MD, PhD
+82-2-2072-1014
Time Frame
Start Date: 2024-10-04
Estimated Completion Date: 2030-09
Participants
Target number of participants: 4016
Treatments
Experimental: Intensive group
Target LDL-cholesterol \<70 mg/dL
Active_comparator: Standard group
Target LDL-cholesterol 90-110 mg/dL
Sponsors
Leads: Seoul National University Hospital
Collaborators: Hanmi Pharmaceutical co., ltd.

This content was sourced from clinicaltrials.gov