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| ID | Type | Description | Link |
|---|---|---|---|
| KCT0009043 | Registry Identifier | CRIS |
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| Name | Class |
|---|---|
| Hanmi Pharmaceutical co., ltd. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive group | Experimental | Target LDL-cholesterol <70 mg/dL |
|
| Standard group | Active Comparator | Target LDL-cholesterol 90-110 mg/dL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Statins and/or Ezetimibe | Drug | Statin ± Ezetimibe to achieve target LDL-cholesterol level |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular event | 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). | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Any stroke | Ischemic stroke, transient ischemic attack, or hemorrhagic stroke | 4 years |
| Ischemic stroke or transient ischemic attack | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wookjin Yang, MD, PhD | Contact | +82-70-4352-2482 | ywj_2002@naver.com | |
| Seung-Hoon Lee, MD, PhD | Contact | +82-2-2072-1014 |
| Name | Affiliation | Role |
|---|---|---|
| Seung-Hoon Lee, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Recruiting | Ansan | South Korea | |||
| Hallym University Sacred Heart Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7678184 | Background | 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. | |
| 19228842 | Background |
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Prospective, Randomized, Open-label, Blinded Endpoint (PROBE) trial
| PCSK9 inhibitor | Drug | The use of PCSK9 inhibitors is permitted to achieve target LDL-cholesterol levels in participants who did not reach the target with statins ± ezetimibe. |
|
| Cardiovascular death | 4 years |
| Myocardial infarction | 4 years |
| Any death | 4 years |
| Acute coronary syndrome | ST-elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina | 4 years |
| Recruiting |
| Anyang |
| South Korea |
| Pusan National University Hospital | Recruiting | Busan | South Korea |
| Gyeongsang National University Changwon Hospital | Recruiting | Changwon | South Korea |
| Samsung Changwon Hospital | Recruiting | Changwon | South Korea |
| Chungbuk National University Hospital | Recruiting | Cheongju-si | South Korea |
| Hallym University Chuncheon Sacred Heart Hospital | Recruiting | Chuncheon | South Korea |
| Kangwon National University Hospital | Recruiting | Chuncheon | South Korea |
| Daegu Catholic University Medical Center | Recruiting | Daegu | South Korea |
| Keimyung University Dongsan Medical Center | Recruiting | Daegu | South Korea |
| Kyungpook National University Chilgok Hospital | Recruiting | Daegu | South Korea |
| Kyungpook National University Hospital | Recruiting | Daegu | South Korea |
| Chungnam National University Hospital | Recruiting | Daejeon | South Korea |
| Daejeon Eulji Medical Center | Recruiting | Daejeon | South Korea |
| Dongguk University Ilsan Hospital | Recruiting | Goyang | South Korea |
| Ilsan Paik Hospital | Recruiting | Goyang | South Korea |
| National Health Insurance Service Ilsan Hospital | Recruiting | Goyang | South Korea |
| Hanyang University Guri Hospital | Recruiting | Guri-si | South Korea |
| Chonnam National University Hospital | Recruiting | Gwangju | South Korea |
| Chosun University Hospital | Recruiting | Gwangju | South Korea |
| Chung-Ang University Gwangmyeong Hospital | Recruiting | Gwangmyeong | South Korea |
| Dongtan Sacred Heart Hospital | Recruiting | Hwaseong | South Korea |
| Wonkwang University Hospital | Recruiting | Iksan | South Korea |
| Gachon University Gil Medical Center | Recruiting | Incheon | South Korea |
| Inha University Hospital | Recruiting | Incheon | South Korea |
| International St. Mary's Hospital | Recruiting | Incheon | South Korea |
| Jeju National University Hospital | Recruiting | Jeju City | South Korea |
| Seoul National University Bundang Hospital | Recruiting | Seongnam | South Korea |
| Asan Medical Center | Not yet recruiting | Seoul | South Korea |
| Chung-Ang University Hospital | Recruiting | Seoul | South Korea |
| Ewha Womans University Mokdong Hospital | Recruiting | Seoul | South Korea |
| Ewha Womans University Seoul Hospital | Recruiting | Seoul | South Korea |
| Gangnam Severance Hospital | Recruiting | Seoul | South Korea |
| Hallym University Kangdong Sacred Heart Hospital | Recruiting | Seoul | South Korea |
| Hanyang University Seoul Hospital | Recruiting | Seoul | South Korea |
| Konkuk University Medical Center | Recruiting | Seoul | South Korea |
| Korea University Anam Hospital | Recruiting | Seoul | South Korea |
| Kyung Hee University Medical Center | Recruiting | Seoul | South Korea |
| National Medical Center | Recruiting | Seoul | South Korea |
| Nowon Eulji Medical Center | Recruiting | Seoul | South Korea |
| Samsung Medical Center | Recruiting | Seoul | South Korea |
| Seoul Metropolitan Government-Seoul National University Boramae Medical Center | Recruiting | Seoul | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
| Severance Hospital | Recruiting | Seoul | South Korea |
| Yeouido St. Mary's Hospital | Recruiting | Seoul | South Korea |
| Yongin Severance Hospital | Recruiting | Yongin | South Korea |
| 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. |
| 37236211 | Background | 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. |
| 18077795 | Background | 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. |
| 26060798 | Background | 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. |
| 26501105 | Background | 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. |
| 23899749 | Background | 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. |
| 31738483 | Background | 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. |
| 34024117 | Background | 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. |
| 16899775 | Background | 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. |
| 30558400 | Background | 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. |
| 42047198 | Derived | Yang W, Song TJ, Koh SH, Jeong HS, Sohn SI, Kim YS, Kim BJ, Jung JM, Jung KH, Kim JM, Jang H, Lee EJ, Chung M, Kim S, Park HK, Yu S, Cho YJ, Kim JT, Kim Y, Kim C, Kim HY, Oh MS, Kim DH, Lee YB, Eun MY, Park HY, Kang K, Kwon HM, Cho HJ, Kim JG, Choi JC, Yoo J, Nam HS, Ok T, Cho AH, Lee JY, Shin JY, Park JH, Park KY, Shin DI, Do Y, Chang Y, Jung S, Jung YH, Seo WK, Jeong SW, Ha SY, An SJ, Ahn SH, Hwang YH, Lee SH. SVO70 (Optimal Target Low-Density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke): Rationale and Study Design. J Am Heart Assoc. 2026 May 5;15(9):e046824. doi: 10.1161/JAHA.125.046824. Epub 2026 Apr 28. |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D059345 | Cerebral Small Vessel Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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