NCT06649240Toboroz
Optimal Target Low-density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke
Optimal Target Low-density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke (SVO70)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 11.
Rövid összefoglaló (regiszter, angolul)
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, baseline LDL-cholesterol <70 mg/dL in the absence of lipid-lowering therapy, 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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 4016 (tervezett)
- Első benyújtás
- 2024. okt. 14.
- Kezdés
- 2024. okt. 4.
- Elsődleges befejezés
- 2030. szept.
- Fő szponzor
- Seoul National University Hospital
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT06649240
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 4016
- 2024. okt. 4. és az elsődleges befejezés (2030. szept.) között
- 46 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Más betegség
- History of atherosclerotic ischemic stroke or transient ischemic attack
- Documented coronary artery disease
- Documented peripheral artery disease or aortic atherosclerotic disease
Laborértékek
- Diabetes with one or more of the following: duration ≥10 years; ≥2 major risk factors (men ≥45 years, women ≥55 years; family history of premature atherosclerotic cardiovascular disease; hypertension; current smoking; or HDL cholesterol <40 mg/dL); or known evidence of target organ damage (albuminuria, estimated glomerular filtration rate <60 mL/min per 1.73 m², retinopathy, neuropathy, or left ventricular hypertrophy)
- Baseline LDL cholesterol <70 mg/dL in the absence of lipid-lowering therapy (statins, ezetimibe, PCSK9 inhibitors, etc.)
- 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)
Egyéb
- Extracranial or intracranial large artery stenosis ≥50%
- 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
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 19 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (46)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Korea University Ansan Hospital | Ansan | Dél-Korea | Toboroz |
| Hallym University Sacred Heart Hospital | Anyang | Dél-Korea | Toboroz |
| Pusan National University Hospital | Busan | Dél-Korea | Toboroz |
| Gyeongsang National University Changwon hospital | Changwon | Dél-Korea | Toboroz |
| Samsung Changwon Hospital | Changwon | Dél-Korea | Toboroz |
| Chungbuk National University Hospital | Cheongju-si | Dél-Korea | Toboroz |
| Hallym University Chuncheon Sacred Heart Hospital | Chuncheon | Dél-Korea | Toboroz |
| Kangwon National University Hospital | Chuncheon | Dél-Korea | Toboroz |
| Keimyung University - Dongsan Medical Center | Daegu | Dél-Korea | Toboroz |
| Kyungpook National University Chilgok Hospital | Daegu | Dél-Korea | Toboroz |
| Kyungpook National University Hospital | Daegu | Dél-Korea | Toboroz |
| Daegu Catholic University Medical Center | Daegu | Dél-Korea | Toboroz |
| Chungnam National University Hospital | Daejeon | Dél-Korea | Toboroz |
| Daejeon Eulji Medical Center | Daejeon | Dél-Korea | Toboroz |
| National Health Insurance Service Ilsan Hospital | Goyang | Dél-Korea | Toboroz |
| Dongguk University Ilsan Hospital | Goyang | Dél-Korea | Visszavonva |
| Ilsan Paik Hospital | Goyang | Dél-Korea | Toboroz |
| Hanyang University Guri Hospital | Guri-si | Dél-Korea | Toboroz |
| Chosun University Hospital | Gwangju | Dél-Korea | Visszavonva |
| Chonnam National University Hospital | Gwangju | Dél-Korea | Toboroz |
| Chung-Ang University Gwangmyeong Hospital | Gwangmyeong | Dél-Korea | Toboroz |
| Dongtan Sacred Heart Hospital | Hwaseong | Dél-Korea | Toboroz |
| Wonkwang University Hospital | Iksan | Dél-Korea | Toboroz |
| Inha University Hospital | Incheon | Dél-Korea | Toboroz |
| International St. Mary's Hospital | Incheon | Dél-Korea | Visszavonva |
| Gachon University Gil Medical Center | Incheon | Dél-Korea | Toboroz |
| Jeju National University Hospital | Jeju City | Dél-Korea | Toboroz |
| Seoul National University Bundang Hospital | Seongnam | Dél-Korea | Toboroz |
| Korea University Anam Hospital | Seoul | Dél-Korea | Toboroz |
| Asan Medical Center | Seoul | Dél-Korea | Toboroz |
| National Medical Center | Seoul | Dél-Korea | Toboroz |
| Gangnam Severance Hospital | Seoul | Dél-Korea | Toboroz |
| Kyung Hee University Medical Center | Seoul | Dél-Korea | Toboroz |
| Konkuk University Medical Center | Seoul | Dél-Korea | Toboroz |
| Ewha Womans University Seoul Hospital | Seoul | Dél-Korea | Toboroz |
| Severance hospital | Seoul | Dél-Korea | Toboroz |
| Seoul National University Hospital | Seoul | Dél-Korea | Toboroz |
| Hallym University Kangdong Sacred Heart Hospital | Seoul | Dél-Korea | Toboroz |
| Samsung Medical Center | Seoul | Dél-Korea | Toboroz |
| Yeouido St. Mary's Hospital | Seoul | Dél-Korea | Toboroz |
| Hanyang University Seoul Hospital | Seoul | Dél-Korea | Toboroz |
| Nowon Eulji Medical Center | Seoul | Dél-Korea | Toboroz |
| Seoul Metropolitan Government Seoul National University Boramae Medical Center | Seoul | Dél-Korea | Toboroz |
| Ewha Womans University Mokdong Hospital | Seoul | Dél-Korea | Toboroz |
| Chung ang University Hospital | Seoul | Dél-Korea | Toboroz |
| Yongin Severance Hospital | Yŏngin | Dél-Korea | Toboroz |
Kapcsolódó publikációk
- SVO70 (Optimal Target Low-Density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke): Rationale and Study Design.J Am Heart Assoc · 2026 · PMID 42047198
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