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NCT Number: NCT06339411

Exploring Cerebrolysin in Late Thrombectomy for Stroke: Blood-brain Barrier Biomarkers and Imaging Insights

Background:

Stroke is a leading cause of mortality and disability globally, with acute ischemic strokes(AIS) due to Large Vessel Occlusion (LVO) presenting significant treatment challenges. Mechanical thrombectomy (MT) has emerged as an effective intervention for AIS within an 8-hour window from symptom onset. However, the potential to extend this window up to 24 hours for select patients could revolutionize outcomes for those arriving late at comprehensive stroke centers. This study investigates the efficacy and safety of Cerebrolysin as an adjunct therapy to MT in extended time window and improving patient recovery.

Methods:

We conducted a multi-center, prospective, randomized study within the Chang Gung Memorial Hospital system in Taiwan, targeting 100 AIS patients eligible for MT beyond the traditional 8-hour window. Participants were randomized to receive either standard care or Cerebrolysin post-MT, initiated within 24 hours of stroke onset and continued for 14 days. The study assessed neurological, neuropsychological, and biomarker outcomes at multiple time points post-stroke to evaluate the effects of Cerebrolysin on recovery.

Results:

The primary outcome will measure the proportion of patients achieving favorable functional outcomes (modified Rankin Scale 0-2) at 90 days. Secondary outcomes include the impact of Cerebrolysin on secondary hemorrhagic transformation, brain edema, mortality rates, and quality of life. The study aims to provide comprehensive data on the benefits of adding Cerebrolysin to the standard post-MT care, focusing on its potential to protect against reperfusion injuries and maintain blood-brain barrier integrity.

Conclusion:

By evaluating the role of Cerebrolysin in conjunction with MT, this study aims to extend the therapeutic window for AIS treatment, offering hope for improved outcomes for patients who would otherwise be ineligible for current reperfusion therapies. The findings may pave the way for new guidelines in stroke management, emphasizing the importance of integrated care approaches in enhancing patient recovery.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients capable of initiating endovascular therapy between 8-24 hours after the time they were last known to be well.
Age above 18 years.
NIHSS (National Institutes of Health Stroke Scale) score of ≥6, indicating moderate to severe stroke.
Presence of likely salvageable ischemic brain tissue, as determined by CT (Computed Tomography) with ASPECTs (Alberta Stroke Program Early CT Score) ≥3.
Occlusion of the proximal MCA-M1 (middle cerebral artery - M1 segment) or ICA (internal carotid artery) detected on CT angiography.
Infarct volume <70 ml on Perfusion CT.
Ischemic tissue showing an infarct volume ratio ≥1.8 on Perfusion CT.
Absolute volume of potentially reversible ischemia (penumbra) ≥15 ml.
Minimal pre-existing disability, with a Modified Rankin Scale (mRS) score of 0-2

Exclusion criteria

Pregnancy
Pre-existing terminal or debilitating illness
Seizure activity preventing accurate determination of NIHSS score
Abnormal blood glucose levels, with values below 50mg/dl or above 400mg/dl
Platelet count <50,000 or International Normalized Ratio (INR) >3, indicating abnormal blood clotting parameters
Neuroimaging findings indicating unsuitability for the procedure, such as ASPECTS score <3 on non-contrast CT, presence of intracranial tumor, acute intracranial hemorrhage, or occlusions in multiple vascular territories.

Treatment and study plan

Cerebrolysin

Drug

Cerebrolysin post-mechanical thrombectomy, initiated within 24 hours of stroke onset and continued for 14 days. The study assessed neurological, neuropsychological, and biomarker outcomes at multiple time points post-stroke to evaluate the effects of Cerebrolysin on recovery.

Primary outcomes

Functional Recovery and Complication Rates Post-Thrombectomy

Time frame: mRS at 90 days and 12 months; NIHSS at 0, 1, and 7 days; mortality and Barthel Index at 90 days and 12 months post-stroke.

This study will assess functional recovery primarily through the proportion of subjects achieving a favorable outcome as defined by an mRS score of 0-2. Secondary measures of efficacy will include changes in NIHSS scores at acute (day 0), subacute (day 1), and early convalescent (day 7) phases post-stroke. The incidence of complications such as secondary intracranial hemorrhage (ICH) or hemorrhage transformation (HT), as well as brain edema with midline shift, will be monitored. Mortality rates and functional independence, measured by the Barthel Index, will be evaluated to provide a comprehensive assessment of patient recovery and treatment impact.

Secondary outcomes

Imaging and High cortical Functional Assessment Endpoints

Time frame: Imaging endpoints will be quantified at 30 days (1 month) and at 90 days (3 months) post-stroke. For functional and mood assessments within the Cerebrolysin group, evaluations will be precisely scheduled at 30 days post-stroke to establish early recovery

Secondary outcomes will include imaging endpoints to measure the impact of Cerebrolysin on cerebral tissue preservation, specifically evaluating final infarct volume, infarct growth, and penumbral salvage. Functional assessments will track changes in language function using the 15-item Boston Naming Test, global cognitive function via the Montreal Cognitive Assessment, and mood disturbances with the Hamilton Depression Rating Scale. These assessments will collectively inform on the neuroprotective effects of Cerebrolysin.

Study contacts

Contact information is provided by the study sponsor or research team.

Chien H Chang, MD

CONTACT

[email protected]

+886975365672

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Examining the Efficacy of Cerebrolysin-Augmented Extended Time Window Thrombectomy in Acute Ischemic Stroke: An In-depth Study of Blood-brain Barrier Biomarkers and Imaging Indicators

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Apr 1, 2024
Registry last updated: Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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