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Trial · Interventional

Not yet recruitingPhase 2Registry data

Cerebrolysin After Reperfusion in Extended-window EndoVascular Thrombectomy

Short name CARE-EVT

NCTNCT06339411 (opens ClinicalTrials.gov in a new tab)Other id202302239A3
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Phase 2
Enrollment
100 participants (estimated)
Sponsor
Chang Gung Memorial Hospital · Other
Design
Randomized · Triple masking
Countries
Not stated
Start
1 Sept 2026 (estimated)
Primary completion
31 Dec 2029 (estimated)
Completion
31 Dec 2030 (estimated)
First posted
1 Apr 2024
Last update posted
11 Aug 2026
Conditions
Acute Ischemic Stroke

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028202920302031
  1. Ph 2

    CARE-EVT

    NCT06339411

    est. 1 Sept 2026 to est. 31 Dec 2030

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • CerebrolysinDrug
  • Normal saline placeboDrug

Arms2

  • Experimental

    Cerebrolysin After Successful Extended-Window Thrombectomy

    Participants will receive Cerebrolysin 30 mL diluted in 70 mL normal saline, administered intravenously over 60 minutes once daily for 10 consecutive days. The first infusion will begin after successful endovascular reperfusion and randomization and within 36 hours of stroke onset. All participants will also receive standard post-thrombectomy stroke care, secondary prevention, and rehabilitation.

  • Placebo comparator

    Matched Placebo After Successful Extended-Window Thrombectomy

    Participants will receive 100 mL normal saline placebo, administered intravenously over 60 minutes once daily for 10 consecutive days according to the same schedule as the experimental arm. The first infusion will begin after successful endovascular reperfusion and randomization and within 36 hours of stroke onset. All participants will also receive standard post-thrombectomy stroke care, secondary prevention, and rehabilitation.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Final Infarct Volume on Diffusion-Weighted MRI

    Time frame · Day 7 to Day 10 after stroke onset

    Registry description

    Final infarct volume will be quantified on Day 7-10 diffusion-weighted magnetic resonance imaging using standardized semiautomated lesion segmentation with manual correction when required. Imaging readers will be blinded to treatment allocation. Participants who are unable to undergo MRI will remain in the intention-to-treat population, and missing primary-outcome data will be addressed using prespecified imputation and sensitivity analyses.

Secondary outcomes(6)

  1. Functional Independence Defined as Modified Rankin Scale Score 0-2

    Time frame · Month 3 and Month 12 after stroke onset

    Registry description

    The proportion of participants achieving functional independence, defined as a modified Rankin Scale score of 0 to 2, will be assessed using a validated structured interview.

  2. Symptomatic Intracranial Hemorrhage

    Time frame · Within 7 days after stroke onset

    Registry description

    Symptomatic intracranial hemorrhage will be defined according to the ECASS III criteria.

  3. Change in Computed Tomography Perfusion-Derived Blood-Brain Barrier Permeability

    Time frame · Pre-EVT and 24 ± 6 hours after reperfusion

    Registry description

    Blood-brain barrier permeability surface area product will be measured using the Patlak model before thrombectomy and approximately 24 hours after reperfusion. The change from baseline will be compared between treatment groups.

  4. Plasma Claudin-5 Concentration-Time Profile

    Time frame · At groin puncture before reperfusion, 24 ± 6 hours after reperfusion, and Day 7 ± 1

    Registry description

    Plasma Claudin-5 concentrations will be measured as an exploratory marker of endothelial tight-junction injury.

  5. Montreal Cognitive Assessment Score

    Time frame · Months 3, 6, and 12

    Registry description

    Global cognitive function will be assessed using the Montreal Cognitive Assessment, with lower scores indicating greater cognitive impairment.

  6. Recurrent Stroke

    Time frame · Through Month 12

    Registry description

    The occurrence of recurrent ischemic or hemorrhagic stroke will be recorded through clinical follow-up and review of available medical records.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Current pregnancy or breastfeeding. * Known iodinated contrast allergy that precludes required endovascular or imaging procedures. * Acute or chronic renal failure with creatinine clearance less than 30 mL/min. * Known hypersensitivity or contraindication to Cerebrolysin. * 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. * Seizure at stroke onset that prevents reliable neurological assessment. * Pre-existing intracranial hemorrhage or multiple vascular occlusions on baseline neuroimaging.

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