Clinical trial NCT06339411: Exploring Cerebrolysin in Late Thrombectomy for Stroke: Blood-brain Barrier Biomarkers and Imaging Insights
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Acute Ischemic Stroke
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Functional Recovery and Complication Rates Post-Thrombectomy
timeFrame: 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.
Secondary outcomes:
measure: Imaging and High cortical Functional Assessment Endpoints
timeFrame: 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
Other outcomes:
Locations:
Study officials:
References: