Optimal Target Low-density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke
NCT ID: NCT06649240
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
4016 participants
INTERVENTIONAL
2024-10-04
2030-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intensive group
Target LDL-cholesterol \<70 mg/dL
Statins and/or Ezetimibe
Statin ± Ezetimibe to achieve target LDL-cholesterol level
PCSK9 inhibitor
The use of PCSK9 inhibitors is permitted to achieve target LDL-cholesterol levels in participants who did not reach the target with statins ± ezetimibe.
Standard group
Target LDL-cholesterol 90-110 mg/dL
Statins and/or Ezetimibe
Statin ± Ezetimibe to achieve target LDL-cholesterol level
PCSK9 inhibitor
The use of PCSK9 inhibitors is permitted to achieve target LDL-cholesterol levels in participants who did not reach the target with statins ± ezetimibe.
Interventions
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Statins and/or Ezetimibe
Statin ± Ezetimibe to achieve target LDL-cholesterol level
PCSK9 inhibitor
The use of PCSK9 inhibitors is permitted to achieve target LDL-cholesterol levels in participants who did not reach the target with statins ± ezetimibe.
Eligibility Criteria
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Inclusion Criteria
2. Patients with objectively confirmed small vessel occlusive infarctions in the subcortical or brainstem regions, identified through neuroimaging (MRI or CT)
3. Patients with a history of symptomatic ischemic stroke caused by the lesion described 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 Criteria
2. 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)
3. Women who are pregnant, breastfeeding, or intending to become pregnant during the study period
4. Deemed unsuitable for participation in the study for more than four years, as per the investigators' discretion
19 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical co., ltd.
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Seung-Hoon Lee
Professor
Principal Investigators
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Seung-Hoon Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Korea University Ansan Hospital
Ansan, , South Korea
Hallym University Sacred Heart Hospital
Anyang, , South Korea
Pusan National University Hospital
Busan, , South Korea
Gyeongsang National University Changwon Hospital
Changwon, , South Korea
Samsung Changwon Hospital
Changwon, , South Korea
Chungbuk National University Hospital
Cheongju-si, , South Korea
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, , South Korea
Kangwon National University Hospital
Chuncheon, , South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Daejeon Eulji Medical Center
Daejeon, , South Korea
Dongguk University Ilsan Hospital
Goyang, , South Korea
Ilsan Paik Hospital
Goyang, , South Korea
National Health Insurance Service Ilsan Hospital
Goyang, , South Korea
Hanyang University Guri Hospital
Guri-si, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Chosun University Hospital
Gwangju, , South Korea
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, , South Korea
Dongtan Sacred Heart Hospital
Hwaseong, , South Korea
Wonkwang University Hospital
Iksan, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Inha University Hospital
Incheon, , South Korea
International St. Mary's Hospital
Incheon, , South Korea
Jeju National University Hospital
Jeju City, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Asan Medical Center
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Ewha Womans University Seoul Hospital
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Hallym University Kangdong Sacred Heart Hospital
Seoul, , South Korea
Hanyang University Seoul Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Kyung Hee University Medical Center
Seoul, , South Korea
National Medical Center
Seoul, , South Korea
Nowon Eulji Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Yeouido St. Mary's Hospital
Seoul, , South Korea
Yongin Severance Hospital
Yŏngin, , South Korea
Countries
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Central Contacts
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Seung-Hoon Lee, MD, PhD
Role: CONTACT
References
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Adams HP Jr, Bendixen BH, Kappelle LJ, Biller J, Love BB, Gordon DL, Marsh EE 3rd. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993 Jan;24(1):35-41. doi: 10.1161/01.str.24.1.35.
Amarenco P, Benavente O, Goldstein LB, Callahan A 3rd, Sillesen H, Hennerici MG, Gilbert S, Rudolph AE, Simunovic L, Zivin JA, Welch KM; Stroke Prevention by Aggressive Reduction in Cholesterol Levels Investigators. Results of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial by stroke subtypes. Stroke. 2009 Apr;40(4):1405-9. doi: 10.1161/STROKEAHA.108.534107. Epub 2009 Feb 19.
Duering M, Biessels GJ, Brodtmann A, Chen C, Cordonnier C, de Leeuw FE, Debette S, Frayne R, Jouvent E, Rost NS, Ter Telgte A, Al-Shahi Salman R, Backes WH, Bae HJ, Brown R, Chabriat H, De Luca A, deCarli C, Dewenter A, Doubal FN, Ewers M, Field TS, Ganesh A, Greenberg S, Helmer KG, Hilal S, Jochems ACC, Jokinen H, Kuijf H, Lam BYK, Lebenberg J, MacIntosh BJ, Maillard P, Mok VCT, Pantoni L, Rudilosso S, Satizabal CL, Schirmer MD, Schmidt R, Smith C, Staals J, Thrippleton MJ, van Veluw SJ, Vemuri P, Wang Y, Werring D, Zedde M, Akinyemi RO, Del Brutto OH, Markus HS, Zhu YC, Smith EE, Dichgans M, Wardlaw JM. Neuroimaging standards for research into small vessel disease-advances since 2013. Lancet Neurol. 2023 Jul;22(7):602-618. doi: 10.1016/S1474-4422(23)00131-X. Epub 2023 May 23.
Goldstein LB, Amarenco P, Szarek M, Callahan A 3rd, Hennerici M, Sillesen H, Zivin JA, Welch KM; SPARCL Investigators. Hemorrhagic stroke in the Stroke Prevention by Aggressive Reduction in Cholesterol Levels study. Neurology. 2008 Jun 10;70(24 Pt 2):2364-70. doi: 10.1212/01.wnl.0000296277.63350.77. Epub 2007 Dec 12.
Mok V, Kim JS. Prevention and Management of Cerebral Small Vessel Disease. J Stroke. 2015 May;17(2):111-22. doi: 10.5853/jos.2015.17.2.111. Epub 2015 May 29.
Hosomi N, Nagai Y, Kohriyama T, Ohtsuki T, Aoki S, Nezu T, Maruyama H, Sunami N, Yokota C, Kitagawa K, Terayama Y, Takagi M, Ibayashi S, Nakamura M, Origasa H, Fukushima M, Mori E, Minematsu K, Uchiyama S, Shinohara Y, Yamaguchi T, Matsumoto M; J-STARS Collaborators. The Japan Statin Treatment Against Recurrent Stroke (J-STARS): A Multicenter, Randomized, Open-label, Parallel-group Study. EBioMedicine. 2015 Aug 6;2(9):1071-8. doi: 10.1016/j.ebiom.2015.08.006. eCollection 2015 Sep.
Amarenco P, Bogousslavsky J, Caplan LR, Donnan GA, Wolf ME, Hennerici MG. The ASCOD phenotyping of ischemic stroke (Updated ASCO Phenotyping). Cerebrovasc Dis. 2013;36(1):1-5. doi: 10.1159/000352050. Epub 2013 Jul 30.
Amarenco P, Kim JS, Labreuche J, Charles H, Abtan J, Bejot Y, Cabrejo L, Cha JK, Ducrocq G, Giroud M, Guidoux C, Hobeanu C, Kim YJ, Lapergue B, Lavallee PC, Lee BC, Lee KB, Leys D, Mahagne MH, Meseguer E, Nighoghossian N, Pico F, Samson Y, Sibon I, Steg PG, Sung SM, Touboul PJ, Touze E, Varenne O, Vicaut E, Yelles N, Bruckert E; Treat Stroke to Target Investigators. A Comparison of Two LDL Cholesterol Targets after Ischemic Stroke. N Engl J Med. 2020 Jan 2;382(1):9. doi: 10.1056/NEJMoa1910355. Epub 2019 Nov 18.
Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.
Amarenco P, Bogousslavsky J, Callahan A 3rd, Goldstein LB, Hennerici M, Rudolph AE, Sillesen H, Simunovic L, Szarek M, Welch KM, Zivin JA; Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Investigators. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med. 2006 Aug 10;355(6):549-59. doi: 10.1056/NEJMoa061894.
Kim JY, Kang K, Kang J, Koo J, Kim DH, Kim BJ, Kim WJ, Kim EG, Kim JG, Kim JM, Kim JT, Kim C, Nah HW, Park KY, Park MS, Park JM, Park JH, Park TH, Park HK, Seo WK, Seo JH, Song TJ, Ahn SH, Oh MS, Oh HG, Yu S, Lee KJ, Lee KB, Lee K, Lee SH, Lee SJ, Jang MU, Chung JW, Cho YJ, Choi KH, Choi JC, Hong KS, Hwang YH, Kim SE, Lee JS, Choi J, Kim MS, Kim YJ, Seok J, Jang S, Han S, Han HW, Hong JH, Yun H, Lee J, Bae HJ. Executive Summary of Stroke Statistics in Korea 2018: A Report from the Epidemiology Research Council of the Korean Stroke Society. J Stroke. 2019 Jan;21(1):42-59. doi: 10.5853/jos.2018.03125. Epub 2018 Dec 18.
Other Identifiers
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KCT0009043
Identifier Type: REGISTRY
Identifier Source: secondary_id
H-2310-119-1479
Identifier Type: -
Identifier Source: org_study_id
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