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Cerebrolysin After Reperfusion in Extended-window EndoVascular Thrombectomy

Study acronym: CARE-EVT
StatusNot Yet Recruiting
PhasePhase 2
Started2026-09-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 36 months later Dec 31, 2026 → Dec 31, 2029
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Chang Gung Memorial Hospital

Amendment history

2026-08-09
Study Identification, Study Status, Eligibility v3
Phase changed: Early Phase 1 → Phase 2
Primary endpoint(s) modified1 entry, revised
WasFunctional Recovery and Complication Rates Post-Thrombectomy
NowFinal Infarct Volume on Diffusion-Weighted MRI
Primary completion pushed: 2026-12-31 → 2029-12-31
Completion pushed: 2027-07-31 → 2030-12-31
Eligibility criteria-430 characters
Inclusion Criteria: Age 18 to 80 years. Acute anterior-circulation ischemic stro [...] rom the participant or a legally authorized representative. Participant assent will also be sought whenever feasible. Exclusion Criteria: Life expectancy less than 6 months or a serious medical, neu [...] or greater than 400 mg/dL. Platelet count less than 50,000/mm³mm3 or international normalized ratio greater than 3. Seizure a [...] ge or multiple vascular occlusions on baseline neuroimaging. -------------------------------------------------------------------------------------------------------------------- Aphasia alone will [...]
Study title+15 characters
Cerebrolysin After Reperfusion in Extended-Windowwindow EndovascularEndoVascular Thrombectomy
2026-08-06
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v2
PhaseEarly Phase 1→Phase 2
Primary completion date2026-12-31→2029-12-31
Completion date2027-07-31→2030-12-31
Start date2024-05-01→2026-09-01
InterventionsCerebrolysin (Drug)→Cerebrolysin (Drug), Normal saline placebo (Drug)
Eligibility criteria+1,132 characters
Inclusion Criteria: Patients capableAge of initiating endovascular therapy between 8-24 hours after the time they were last known18 to be well. Age above 1880 years. NIHSSAcute (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. B [...] National Institutes of Health Stroke Scale) score of ≥at least 6, indicating moderate to severe stroke. Presence of likely [...] [...]
Secondary endpoints1 to 6 entries
ImagingFunctional andIndependence HighDefined corticalas FunctionalModified Rankin Scale Score 0-2 Symptomatic Intracranial Hemorrhage Change in Computed Tomography Perfusion-Derived Blood-Brain Barrier Permeability Plasma Claudin-5 Concentration-Time Profile Montreal Cognitive Assessment EndpointsScore Recurrent Stroke
Primary endpoints1 entry, revised
FunctionalFinal RecoveryInfarct andVolume Complicationon RatesDiffusion-Weighted Post-ThrombectomyMRI
Study description+2,556 characters
This is an investigator-initiated, multicenter, randomized, placebo-controlled, participant- and outcome-assessor-blinded proof-of-concept trial conducted at three stroke centers within the Chang Gung Memorial Hospital system in Taiwan. The study will enroll 100 participants aged 18 to 80 years with [...]
Collaborators+22 characters
EVER Pharma France SAS
Study title-47 characters
Exploring Cerebrolysin inAfter LateExtended-Window Endovascular Thrombectomy for Stroke: Blood-brain Barrier Biomarkers and Imaging Insights
2024-03-31
Study Identification, Study Status, Arms and Interventions, Outcome Measures v1
Study title+16 characters
Exploring Cerebrolysin in Late Thrombectomy for Stroke: BBBBlood-brain Barrier Biomarkers and Imaging Insights
2024-03-25
Original filing
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.
Trial Details
NCT Number NCT06339411
Lead Sponsor Chang Gung Memorial Hospital
Collaborators: EVER Pharma France SAS
Conditions Acute Ischemic Stroke
Enrollment 100 participants
Start Date 2026-09-01
Primary Completion 2029-12-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-11