Cerebrolysin After Reperfusion in Extended-window EndoVascular Thrombectomy

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

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

Treatments tested in this trial

  • Cerebrolysin
  • Normal saline placebo

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Chang Gung Memorial Hospital

Lead sponsor

EVER Pharma France SAS

Collaborator