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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Israel
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Contact Information
Primary
Ruth Valdman, M.S.c
Ruthva@szmc.org.il
+972549577137
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 30
Treatments
Experimental: Participants undergo EVT plus Cerebrolysin
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.
Related Therapeutic Areas
Sponsors
Leads: Shaare Zedek Medical Center

This content was sourced from clinicaltrials.gov