Efficacy of Cerebrolysin Treatment as an add-on Therapy to Mechanical Thrombectomy in Acute Ischemic Stroke.
Stroke, Ischemic, Stroke, Acute, Stroke Sequelae
About this trial
This is an interventional treatment trial for Stroke, Ischemic focused on measuring acute ischemic stroke, effective recanalization, neuroprotection, cerebrolysin
Eligibility Criteria
Inclusion Criteria:
Clinical Inclusion Criteria:
- Age 18-80 years
- Signs and symptoms consistent with the diagnosis of an anterior circulation AIS
- Stroke onset to groin ≤6h (stroke onset is defined as the time the patient was last known to be at their neurologic baseline (wake-up strokes are eligible if they meet the above time limits).
- mRS ≤1 prior to qualifying stroke (functionally independent for all ADLs)
- moderate to severe stroke: NIHSS score of ≥5 with presence of any cortical signs (gaze, visual fields, language, or neglect)
- Initiation of treatment with Cerebrolysin ≤8h following stroke onset (Cerebrolysin group)
- Patient has signed the Informed Consent form (Cerebrolysin group)
Neuroimaging Inclusion Criteria:
- CT ASPECTS ≥6 prior to MT
- ICA or MCA-M1 or -M2 occlusion (carotid occlusions can be cervical or intracranial; without tandem MCA lesions) by CTA
- Target mismatch profile on CTP (ischemic core volume <70 ml, mismatch ratio ≥1.8 (ischemic penumbra at least 180% larger than the ischemic core volume) and mismatch volume ≥15 ml)
- Moderate-to-good collateral status on multiphase CTA (>50% MCA territory)
- Effective reperfusion mTICI ≥2b following MT
Exclusion Criteria:
Clinical Exclusion Criteria:
- Other serious, advanced, or terminal illness or life expectancy ≤ 6 months
- Pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g. Alzheimer's disease, vascular dementia, Parkinson's disease, demyelinating disease, encephalopathy of any cause,a history of significant alcohol or drugabuse)
- Pregnancy or lactation
- Known allergy to iodine that precludes an endovascular procedure
- Acute or chronic renal failure with calculated creatinine clearance <30 ml/min/1.73m2 or unable to undergo a contrast brain perfusion scan withCT
- Inability to tolerate or comply with studyprocedures
- Any condition that would represent a contraindication for Cerebrolysin administration (e.g.allergy)
Neuroimaging Exclusion Criteria:
- Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion)
- Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation
- Significant mass effect with midline shift
- Treatment with another investigational drug within the last 30 days that may interfere with this study's medications
- Patients with nondiagnostic NCCT or CTP maps
Sites / Locations
- Military Institute of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
active
historical control
The first Cerebrolysin infusion (30 ml mixed with 250 mL of saline) is intended to be initiated as soon as possible after successful recanalization is achieved and within 8h of AIS stroke onset. Cerebrolysin treatment will be continued (30 ml/d) once daily until day 21 (first cycle). The patients will receive a second cycle of treatment (30 ml/d for 21 days given in the Outpatient Department or Neurorehabilitation Clinic) from day 69 to 90 (± 3 days).
Historical data will be obtained by retrospective clinical chart reviews of patients hospitalized in the study center between 2017 and Dec.2020 and fulfilling the same clinical and radiological inclusion criteria in whom 12-month follow-up (including mRS, NIHSS, BI, EQ-5D-5L) could be obtained.