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

NCT06339411 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: 202302239A3
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Functional Recovery and Complication Rates Post-Thrombectomy

  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.

  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 (1)

• Imaging and High cortical Functional Assessment Endpoints

  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

Study Arms (2)

Extended Thrombectomy with Cerebrolysin

EXPERIMENTAL

Cerebrolysin 30milliliter/quaque die(QD) for 10\~14days intravenous drip (IVD)

Drug: Cerebrolysin

Extended Thrombectomy without Cerebrolysin

NO INTERVENTION

No cerebrolysin

Interventions

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.

Extended Thrombectomy with Cerebrolysin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Ischemic Stroke

Interventions

cerebrolysin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Chien H Chang, MD

CONTACT

+886975365672; cva9514@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share