NCT06339411Toborzás még nem indult2. fázis
Cerebrolysin After Reperfusion in Extended-window EndoVascular Thrombectomy
Cerebrolysin After Reperfusion in Extended-Window Endovascular Thrombectomy: A Multicenter Randomized Controlled Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 11.
Rövid összefoglaló (regiszter, angolul)
Acute ischemic stroke caused by blockage of a large brain artery can lead to severe disability. Endovascular thrombectomy is a catheter-based procedure used to remove the blood clot and restore blood flow. It can benefit selected patients treated 6 to 24 hours after stroke onset, but some patients remain disabled even when the blocked artery is successfully reopened. Ongoing injury to brain tissue, small blood vessels, and the blood-brain barrier may contribute to this incomplete recovery. This multicenter randomized clinical trial will evaluate whether Cerebrolysin, given after successful extended-window endovascular thrombectomy, can reduce brain tissue injury and support recovery. The study will enroll 100 adults aged 18 to 80 years at three stroke centers in Taiwan. Participants will be randomly assigned, after successful reperfusion has been confirmed, to receive either Cerebrolysin 30 mL or a matched normal saline placebo by intravenous infusion once daily for 10 consecutive days. The first infusion will begin within 36 hours of stroke onset. All participants will also receive standard stroke care and rehabilitation. The primary outcome is final infarct volume measured by diffusion-weighted magnetic resonance imaging on Day 7 to Day 10. Other outcomes include functional recovery at 3 and 12 months, neurological improvement, symptomatic intracranial hemorrhage, cerebral edema, recurrent stroke, mortality, cognition, language, and mood. The study will also examine blood-brain barrier injury using computed tomography perfusion, dynamic contrast-enhanced magnetic resonance imaging, and serial plasma Claudin-5 measurements. This study will determine whether Cerebrolysin shows evidence of reducing postreperfusion brain injury after successful thrombectomy and will help guide the design of a larger trial focused on clinical outcomes.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 100 (tervezett)
- Első benyújtás
- 2024. márc. 25.
- Kezdés
- 2026. szept. 1.
- Elsődleges befejezés
- 2029. dec. 31.
- Fő szponzor
- Chang Gung Memorial Hospital
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT06339411
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 100
- 2026. szept. 1. és az elsődleges befejezés (2029. dec. 31.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Más betegség
- Life expectancy less than 6 months or a serious medical, neurological, or psychiatric condition likely to interfere with study treatment, follow-up, or outcome assessment.
- Known iodinated contrast allergy that precludes required endovascular or imaging procedures.
- Known hypersensitivity or contraindication to Cerebrolysin.
- Seizure at stroke onset that prevents reliable neurological assessment.
- Pre-existing intracranial hemorrhage or multiple vascular occlusions on baseline neuroimaging.
Laborértékek
- Acute or chronic renal failure with creatinine clearance less than 30 mL/min.
- Aspartate aminotransferase or alanine aminotransferase greater than 2 times the upper limit of normal, or total bilirubin greater than 2 mg/dL.
- Blood glucose less than 50 mg/dL or greater than 400 mg/dL.
- Platelet count less than 50,000/mm3 or international normalized ratio greater than 3.
Egyéb
- Current pregnancy or breastfeeding.
Kiket keres a vizsgálat
- Age 18 to 80 years.
- Acute anterior-circulation ischemic stroke caused by internal carotid artery or M1 or M2 middle cerebral artery occlusion confirmed by computed tomography angiography.
- Stroke onset-to-groin-puncture interval greater than 6 hours and no more than 24 hours.
- Prestroke modified Rankin Scale score of 0 to 2.
- Baseline National Institutes of Health Stroke Scale score of at least 6 with cortical signs.
- Alberta Stroke Program Early Computed Tomography Score greater than 3.
- Computed tomography perfusion target mismatch defined as ischemic core volume less than 70 mL, mismatch ratio at least 1.8, and mismatch volume at least 15 mL.
- Moderate-to-good collateral circulation, defined as filling of more than 50% of the middle cerebral artery territory on computed tomography angiography.
- Successful endovascular reperfusion, defined as modified Thrombolysis in Cerebral Infarction grade 2b or 3, confirmed before randomization.
- Study treatment can be initiated within 36 hours of stroke onset.
- Written informed consent obtained before randomization from the participant or a legally authorized representative.
Életkor a regiszterben: 18 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.