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Exploring Cerebrolysin in Late Thrombectomy for Stroke: Blood-brain Barrier Biomarkers and Imaging Insights - Trial NCT06339411

Access comprehensive clinical trial information for NCT06339411 through Pure Global AI's free database. This Phase 1 trial is sponsored by Chang Gung Memorial Hospital and is currently Not yet recruiting. The study focuses on Acute Ischemic Stroke. Target enrollment is 100 participants.

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NCT06339411
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06339411
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Exploring Cerebrolysin in Late Thrombectomy for Stroke: Blood-brain Barrier Biomarkers and Imaging Insights
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

Study Focus

Acute Ischemic Stroke

Cerebrolysin

Interventional

drug

Sponsor & Location

Chang Gung Memorial Hospital

Timeline & Enrollment

Phase 1

May 01, 2024

Jul 31, 2027

100 participants

Primary Outcome

Functional Recovery and Complication Rates Post-Thrombectomy

Summary

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.

ICD-10 Classifications

Stroke, not specified as haemorrhage or infarction
Sequelae of stroke, not specified as haemorrhage or infarction
Cerebral infarction
Cerebral infarction, unspecified
Transient cerebral ischaemic attack, unspecified

Data Source

ClinicalTrials.gov

NCT06339411

Non-Device Trial