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

Last updated: October 17, 2024
Sponsor: Seoul National University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Thrombosis

Vascular Diseases

Treatment

PCSK9 inhibitor

Statins and/or Ezetimibe

Clinical Study ID

NCT06649240
H-2310-119-1479
KCT0009043
  • Ages > 19
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Age 19 years or older

  2. Patients with objectively confirmed small vessel occlusive infarctions in thesubcortical or brainstem regions, identified through neuroimaging (MRI or CT)

  3. Patients with a history of symptomatic ischemic stroke caused by the lesiondescribed in 2), occurring within 180 days prior to enrollment

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

Exclusion

Exclusion Criteria:

  1. Patients requiring intensive LDL cholesterol management (LDL-C <70 mg/dL) due toanother condition, with LDL cholesterol targets specified in the guidelines for thatcondition

  2. Patients contraindicated for statin use (e.g., active liver disease, serumtransaminase levels elevated more than three times the normal limit, muscledisorders, hypersensitivity to statins, or taking medications contraindicated foruse with statins)

  3. Women who are pregnant, breastfeeding, or intending to become pregnant during thestudy period

  4. Deemed unsuitable for participation in the study for more than four years, as perthe investigators' discretion

Study Design

Total Participants: 4016
Treatment Group(s): 2
Primary Treatment: PCSK9 inhibitor
Phase:
Study Start date:
October 04, 2024
Estimated Completion Date:
September 30, 2030

Connect with a study center

  • Korea University Ansan Hospital

    Ansan,
    Korea, Republic of

    Site Not Available

  • Hallym University Sacred Heart Hospital

    Anyang,
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Gyeongsang National University Changwon Hospital

    Changwon,
    Korea, Republic of

    Active - Recruiting

  • Samsung Changwon Hospital

    Changwon,
    Korea, Republic of

    Site Not Available

  • Chungbuk National University Hospital

    Cheongju,
    Korea, Republic of

    Site Not Available

  • Hallym University Chuncheon Sacred Heart Hospital

    Chuncheon,
    Korea, Republic of

    Site Not Available

  • Kangwon National University Hospital

    Chuncheon,
    Korea, Republic of

    Active - Recruiting

  • Daegu Catholic University Medical Center

    Daegu,
    Korea, Republic of

    Site Not Available

  • Keimyung University Dongsan Medical Center

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Hospital

    Daegu,
    Korea, Republic of

    Site Not Available

  • Chungnam National University Hospital

    Daejeon,
    Korea, Republic of

    Site Not Available

  • Daejeon Eulji Medical Center

    Daejeon,
    Korea, Republic of

    Active - Recruiting

  • Dongguk University Ilsan Hospital

    Goyang,
    Korea, Republic of

    Site Not Available

  • Ilsan Paik Hospital

    Goyang,
    Korea, Republic of

    Site Not Available

  • Hanyang University Guri Hospital

    Guri,
    Korea, Republic of

    Active - Recruiting

  • Chonnam National University Hospital

    Gwangju,
    Korea, Republic of

    Active - Recruiting

  • Chosun University Hospital

    Gwangju,
    Korea, Republic of

    Active - Recruiting

  • Chung-Ang University Gwangmyeong Hospital

    Gwangmyeong,
    Korea, Republic of

    Site Not Available

  • Dongtan Sacred Heart Hospital

    Hwaseong,
    Korea, Republic of

    Site Not Available

  • Wonkwang University Hospital

    Iksan,
    Korea, Republic of

    Active - Recruiting

  • Gachon University Gil Medical Center

    Incheon,
    Korea, Republic of

    Site Not Available

  • Inha University Hospital

    Incheon,
    Korea, Republic of

    Site Not Available

  • International St. Mary's Hospital

    Incheon,
    Korea, Republic of

    Site Not Available

  • Jeju National University Hospital

    Jeju,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam,
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Ewha Womans University Mokdong Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Ewha Womans University Seoul Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Gangnam Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Hallym University Kangdong Sacred Heart Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Hanyang University Seoul Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Konkuk University Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • National Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Nowon Eulji Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul Metropolitan Government-Seoul National University Boramae Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Yeouido St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Yongin Severance Hospital

    Yongin,
    Korea, Republic of

    Active - Recruiting

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