Optimal Target Low-density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke
- Conditions
- Ischemic StrokeSmall Vessel Cerebrovascular DiseaseCholesterol, LDLSecondary PreventionCardiovascular Diseases
- Interventions
- Drug: PCSK9 inhibitor
- Registration Number
- NCT06649240
- Lead Sponsor
- Seoul National University Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4016
- 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
- Patients requiring intensive LDL cholesterol management (LDL-C <70 mg/dL) due to another condition, with LDL cholesterol targets specified in the guidelines for that condition
- Patients contraindicated for statin use (e.g., active liver disease, serum transaminase levels elevated more than three times the normal limit, muscle disorders, hypersensitivity to statins, or taking medications contraindicated for use with statins)
- Women who are pregnant, breastfeeding, or intending to become pregnant during the study period
- Deemed unsuitable for participation in the study for more than four years, as per the investigators' discretion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intensive group Statins and/or Ezetimibe Target LDL-cholesterol \<70 mg/dL Intensive group PCSK9 inhibitor Target LDL-cholesterol \<70 mg/dL Standard group Statins and/or Ezetimibe Target LDL-cholesterol 90-110 mg/dL Standard group PCSK9 inhibitor Target LDL-cholesterol 90-110 mg/dL
- Primary Outcome Measures
Name Time Method Major adverse cardiovascular event 4 years Major adverse cardiovascular event (MACE) includes cardiovascular death, stroke, and acute coronoary syndrome (i.e., ST-elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina).
- Secondary Outcome Measures
Name Time Method Any death 4 years Any stroke 4 years Ischemic stroke, transient ischemic attack, or hemorrhagic stroke
Ischemic stroke or transient ischemic attack 4 years Cardiovascular death 4 years Myocardial infarction 4 years Acute coronary syndrome 4 years ST-elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina
Trial Locations
- Locations (46)
Daejeon Eulji Medical Center
🇰🇷Daejeon, Korea, Republic of
National Health Insurance Service Ilsan Hospital
🇰🇷Goyang, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Gyeongsang National University Changwon Hospital
🇰🇷Changwon, Korea, Republic of
Samsung Changwon Hospital
🇰🇷Changwon, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Cheongju, Korea, Republic of
Hallym University Chuncheon Sacred Heart Hospital
🇰🇷Chuncheon, Korea, Republic of
Kangwon National University Hospital
🇰🇷Chuncheon, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Dongguk University Ilsan Hospital
🇰🇷Goyang, Korea, Republic of
Ilsan Paik Hospital
🇰🇷Goyang, Korea, Republic of
Hanyang University Guri Hospital
🇰🇷Guri, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Chosun University Hospital
🇰🇷Gwangju, Korea, Republic of
Chung-Ang University Gwangmyeong Hospital
🇰🇷Gwangmyeong, Korea, Republic of
Dongtan Sacred Heart Hospital
🇰🇷Hwaseong, Korea, Republic of
Wonkwang University Hospital
🇰🇷Iksan, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
International St. Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Jeju National University Hospital
🇰🇷Jeju, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Hallym University Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Medical Center
🇰🇷Seoul, Korea, Republic of
National Medical Center
🇰🇷Seoul, Korea, Republic of
Nowon Eulji Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Yeouido St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Yongin Severance Hospital
🇰🇷Yongin, Korea, Republic of