A Prospective, Trial About Safety and Efficacy of Combined Treatment With Cerebrolysin in Acute Ischemic Hemispheric Stroke Patients Undergoing EndoVascular Treatment (EVT)

NCT06070753 | Unknown

• 1 other identifier: 0347-21-SZMC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is investigate the efficacy of a neuro/vascular-protective treatment with the drug Cerebrolysin in patients with acute ischemic stroke. starting immediately after completion of a EVT therapy. The main question the study aims to answer is: If a 10 days treatment with the neuro/vascularprotective drug Cerebrolysin (30 ml/day as intravenous infusion) is able to increase the overall outcome of EVT therapy? Participants will receive intravenous treatment with Cerebrolysin (30 ml/day) starting immediately after thrombolytic therapy and being continued for 10 consecutive days as one single daily infusion. The modified Rankin Scale (mRS) 90 days after onset of symptoms will be investigated, but also the improvement in other ratings as well as the time course of the improvement. In addition to the clinical outcome measures the study will assess neuroimaging perfusion CT-Perfusion parameters to evaluate possible direct improvement in microcirculation that might be an additional mechanism of action of cerebrolysin. CT-Perfusion being done immediately after EVT will provide ability to stratify the data according to non-favorable CT-Perfusion parameters after EVT versus favoravle.

Conditions

Acute Ischemic Stroke

Keywords

STROKE; Endovascular Thrombectomy

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale (mRS)

  Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. A standardized interview also exists to try to reduce subjectivity or variability in score assignments. Ranges between 0-6

  90 Days

Secondary Outcomes (5)

• NIH Stroke Scale (NIHSS)

  90 Days

• Glasgow Outcome Score

  90 days

• Geriatric Depression Scale (GDS)

  90 days

• Montreal Cognitive Assessment (MoCA)

  90 days

• Short Form 36 Health Survey (SF36)

  90 days

Other Outcomes (3)

• Symptomatic Intracranial Hemorrhage

  90 Days

• Patient Survivial at Day 90

  90 days

• Stroke related and Neurological Death

  90 days

Study Arms (1)

Participants undergo EVT plus Cerebrolysin

EXPERIMENTAL

one group of patients should receive intravenous treatment with Cerebrolysin (30 ml/day) starting post EVT CT-Perfusion that will be performed not later than 3 hours from completion of EVT. Treatment will be continued for 10 consecutive days as one single daily infusion.

Drug: Cerebrolysin

Interventions

Cerebrolysin DRUG

Cerebrolysin, 30 ml/day as intravenous infusion, first infusion after completion of EVT. Daily infusion for 10 consecutive days.

Also known as: Abrineurin

Participants undergo EVT plus Cerebrolysin

Eligibility Criteria

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

You may qualify if:

• Female or male inpatients.
• Age: ≥18 years.
• MRS ≤2
• Clinical diagnosis of ischemic stroke eligible for EVT.
• No contraindication to undergo CT-Perfusion
• Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the legally authorised representative or two independent physicians, according to the regulatory and legal requirements of israel.

You may not qualify if:

• Brain Imaging
• Evidence of intracranial haemorrhage (ICH) on the CT-scan
• General
• Participation in another therapeutic clinical trial 3 months before baseline
• Female patient of childbearing age must not be pregnant as proved by Beta-HGB negative testing.
• Medical
• Platelet count of below 100x103/mm3
• Blood glucose \<50
• Known haemorrhagic diathesis
• Manifest or recent severe or dangerous bleeding
• Known bacterial endocarditis, pericarditis
• Acute pancreatitis
• Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial-aneurysm, arterial/venous malformation
• Neoplasm with increased bleeding risk
• Severe liver disease, including hepatic failure, cirrhosis, portal hypertension, oesaphageal varices) and active hepatitis

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

cerebrolysin; abrineurin

Condition Hierarchy (Ancestors)

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

Study Officials

• Roni Eichel, M.D.

  Shaare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruth Valdman, M.S.c

CONTACT

+972549577137; Ruthva@szmc.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Eichel- Head of the Neurology Department

Model Details: Open label

Study Record Dates

• First Submitted: June 11, 2023
• First Posted: October 6, 2023
• Study Start: October 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)