Cerebrolysin After Reperfusion in Extended-window EndoVascular Thrombectomy

ConditionAcute Ischemic Stroke

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorChang Gung Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Cerebrolysin
Drug
Cerebrolysin 30 mL diluted in 70 mL normal saline will be administered intravenously over 60 minutes once daily for 10 consecutive days. Treatment will begin after successful endovascular reperfusion and randomization and within 36 hours of stroke onset.
Normal saline placebo
Drug
Normal saline 100 mL will be administered intravenously over 60 minutes once daily for 10 consecutive days according to the same schedule as Cerebrolysin. Infusion bags, drip chambers, and visible tubing will be covered to maintain masking.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Cerebrolysin After Successful Extended-Window ThrombectomyExperimental treatment 1 intervention

Group B: Matched Placebo After Successful Extended-Window ThrombectomyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Final Infarct Volume on Diffusion-Weighted MRI

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.

Time frame

Day 7 to Day 10 after stroke onset

Secondary outcomes

Functional Independence Defined as Modified Rankin Scale Score 0-2

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.

Time frame

Month 3 and Month 12 after stroke onset

Symptomatic Intracranial Hemorrhage

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

Time frame

Within 7 days after stroke onset

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

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.

Time frame

Pre-EVT and 24 ± 6 hours after reperfusion

Plasma Claudin-5 Concentration-Time Profile

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

Time frame

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chang Gung Memorial Hospital

Lead sponsor

EVER Pharma France SAS

Collaborator

Source ClinicalTrials.gov

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