Status:
UNKNOWN
Efficacy of Cerebrolysin Treatment as an add-on Therapy to Mechanical Thrombectomy in Acute Ischemic Stroke.
Lead Sponsor:
Military Institute od Medicine National Research Institute
Collaborating Sponsors:
Brainomix Limited
Conditions:
Stroke, Ischemic
Stroke, Acute
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study is designed to determine the efficacy and safety of Cerebrolysin treatment as an add- on therapy to mechanical thrombectomy (MT) in reducing global disability in subjects with acute ischemi...
Detailed Description
Background The recent endovascular stroke trials have established a new paradigm for acute ischemic stroke (AIS) treatment showing that mechanical thrombectomy (MT) within 6 hours of stroke significa...
Eligibility Criteria
Inclusion
- Clinical
- 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
- 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
- Clinical
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04904341
Start Date
January 1 2021
End Date
December 31 2024
Last Update
August 24 2022
Active Locations (1)
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1
Military Institute of Medicine
Warsaw, Masovian Voivodeship, Poland, 04-141