Evaluating Cerebrolysin for Acute Ischemic Stroke Patients After Endovascular Treatment
A Prospective, Trial About Safety and Efficacy of Combined Treatment With Cerebrolysin in Acute Ischemic Hemispheric Stroke Patients Undergoing EndoVascular Treatment (EVT)
NA · Shaare Zedek Medical Center · NCT06070753
This study is testing if a drug called Cerebrolysin can help people who have had an acute ischemic stroke feel better after they receive a specific treatment to restore blood flow to the brain.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shaare Zedek Medical Center (other) |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT06070753 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of Cerebrolysin, a neuro/vascular-protective drug, in patients with acute ischemic stroke who have undergone endovascular treatment (EVT). Participants will receive intravenous infusions of Cerebrolysin for 10 consecutive days, starting immediately after EVT. The study aims to assess the overall outcomes using the modified Rankin Scale (mRS) and neuroimaging parameters to evaluate improvements in microcirculation. The trial is set to take place at Shaare Zedek Medical Center in Jerusalem.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of ischemic stroke eligible for EVT and a modified Rankin Scale score of 2 or less.
Not a fit: Patients with evidence of intracranial hemorrhage or those with severe bleeding disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from acute ischemic stroke.
How similar studies have performed: While there is some preclinical evidence supporting the use of Cerebrolysin, this specific approach in acute ischemic stroke patients is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: 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 * Major surgery or significant trauma in past 3 months * Multiple serious drug allergies * Hypersensitivity or allergy to one of the components of the drug * Severe renal impairment Psychiatric * Chronic intoxication or chronic substance use disorder with pharmaceuticals, drugs, alcohol or industrial poisons Neurological * Epilepsy * Symptoms suggestive of subarachnoid haemorrhage, even if the CT-scan is normal * Known history of or suspected intracranial haemorrhage * Suspected subarachnoid haemorrhage or condition after subarachnoid hemorrhage from aneurysm * Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) * Haemorrhagic retinopathy, e.g. in diabetes (vision disturbances may indicate haemorrhagic retinopathy)
Where this trial is running
Jerusalem
- Shaare Zedek Medical Center — Jerusalem, Israel (RECRUITING)
Study contacts
- Principal investigator: Roni Eichel, M.D. — Shaare Zedek Medical Center
- Study coordinator: Ruth Valdman, M.S.c
- Email: Ruthva@szmc.org.il
- Phone: +972549577137
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Ischemic Stroke, STROKE, Endovascular Thrombectomy