Condition category
Circulatory System
Date applied
04/05/2020
Date assigned
25/05/2020
Last edited
19/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A stroke is a sudden interruption in the brain's blood supply. Early recanalization (restoring blood supply), brain protection and neurorecovery are the main goals of acute stroke treatment. Growing evidence suggests the beneficial effects of the medicine Cerebrolysin in acute stroke due to its neuroprotective actions (preventing brain cell death). Moreover the influence of Cerebrolysin on blood-brain barrier permeability has been speculated. The aim of this study is to assess the effectiveness and safety of Cerebrolysin in the early recovery phase in acute ischemic stroke after failed recanalization.

Who can participate?
Acute moderate and severe stroke patients, aged 18 or older, after failed recanalization

What does the study involve?
The study involves standard acute stroke assessment, recanalization and post procedural therapy and rehabilitation. For a minimum of 14 and maximum of 21 days patients in the investigational group receive Cerebrolysin as add-on treatment. The control group are 20 matched patients who did not sign the consent for Cerebrolysin treatment but signed the consent to take part in the study as controls. Outcomes are compared in both groups. The follow-up procedure includes routine brain CT or MRI scans (24 hours, 7 days and 6-12 months after symptom onset), and early and late clinical assessment.

What are the possible benefits and risks of participating?
Possible benefit for the participants is better clinical outcome after failed recanalization, regular follow-up by a dedicated stroke neurologist, and contribution to improved knowledge of the best stroke treatment. As the given drug has an excellent safety profile (according to known studies) there are no expected special risks for participants.

Where is the study run from?
University Hospital Centre Zagreb (Croatia)

When is the study starting and how long is it expected to run for?
August 2017 to January 2020

Who is funding the study?
University Hospital Centre Zagreb (Croatia)

Who is the main contact?
Prof. Zdravka Poljakovic
zpoljako@kbc-zagreb.hr

Trial website

Contact information

Type

Scientific

Primary contact

Prof Zdravka Poljakovic

ORCID ID

Contact details

Principal Investigator
University Hospital Centre Zagreb
Kispaticeva 12
Dept. of Neurology
Zagreb
10000
Croatia
+385 (0)12388341
zpoljako@kbc-zagreb.hr

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

EP - 43/17

Study information

Scientific title

Efficacy of Cerebrolysin treatment as an add-on therapy to thrombolysis and thrombectomy in severe stroke patients with unsuccessful reperfusion - a prospective single-center clinical study

Acronym

CEREC-Stroke

Study hypothesis

Cerebrolysin therapy in patients with acute severe stroke after failed reperfusion therapy improves outcome.

Ethics approval

Approved in 02/11/2017, Ethics Committee of University Hospital Zagreb (Etičko Povjerenstvo KBC Zagreb, prof dr sc Darko Marčinko, Klinika za psihijatriju - President, Kišpatićeva 12, 10000 Zagreb, Croatia; no tel; jadranka.gregoran@kbc-zagreb.hr), ref: EP 43/17

Study design

Interventional non-randomized study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Acute ischemic stroke

Intervention

The study group are 20 patients with acute moderate and severe ischemic stroke, treated in University Hospital Centre Zagreb with either thrombolytic therapy alone, or thrombolysis and thrombectomy, who either proven by neuroimaging methods (MRI, MRA, DSA) or clinically (no change in NIHSS in the first 12 hours after recanalisation procedure) fulfil the criteria of unsuccessful reperfusion. Those patients will receive Cerebrolysin (30 ml i.v./day) starting the therapy the latest 24 hours after symptoms onset for a minimum of 14 and a maximum of 21 days. Efficacy will be assessed by NIH Stroke Scale/Score (NIHSS) at 7 and 14 days and early modified Rankin Scale (mRS) (by discharge) and mRS after 90 days and 1 year. Neuroimaging (brain CT or MRI) will be performed 24 hours after recanalisation therapy, on day 7 and a control imaging between 6 and 12 months of follow up. Signs of haemorrhagic transition will be analysed. All other therapeutic measures, as well as rehabilitation, will be according to the standard procedure. The control group are 20 matched patients who did not sign the consent for Cerebrolysin therapy but signed the consent to take part in the study as controls. Outcome measures are compared in both groups.

Intervention type

Drug

Phase

Not Applicable

Drug names

Cerebrolysin

Primary outcome measure

Clinical outcome measured by modified Rankin Scale (mRS) after 12 months

Secondary outcome measures

1. Percentage of patients with haemorrhagic transformation assessed by control neuroimaging (brain CT and/or MRI) in 24 hours and 7 days interval since symptom onset
2. Mortality rate assessed by modified Rankin Scale (mRS) at any point during study follow-up (12 months)
3. Adverse events assessed by routine laboratory or clinical changes during treatment period with Cerebrolysin

Overall trial start date

01/08/2017

Overall trial end date

01/01/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 and over
2. Patients with acute ischemic stroke and initial NIHSS 8 or more
3. Treated in University Hospital Centre Zagreb with either thrombolytic therapy alone, or thrombolysis and thrombectomy, either proven by neuroimaging methods (MRI, MRA, DSA) or clinically (no change in NIHSS in the first 12 hours after recanalisation procedure) to fulfil the criteria of unsuccessful reperfusion

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Total final enrolment

46

Participant exclusion criteria

1. Haemorrhagic transition of a stroke on control CT scan after reperfusion therapy
2. Patients taking MAO inhibitors
3. Patients known to be allergic to the drug
4. Patients taking part in another trial

Recruitment start date

01/01/2018

Recruitment end date

01/01/2019

Locations

Countries of recruitment

Croatia

Trial participating centre

University Hospital Centre Zagreb
Dept. of Neurology Kispaticeva 12
Zagreb
10000
Croatia

Sponsor information

Organisation

University Hospital Centre Zagreb

Sponsor details

Dept. of Neurology
Kispaticeva 12
Zagreb
10000
Croatia
+385 (0)12388341
zdravka.po@gmail.com

Sponsor type

Hospital/treatment centre

Website

https://www.kbc-zagreb.hr/

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Centre Zagreb

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Case report - already published 2020
2. Poster with preliminary results - shown at ESOC 2019
3. Results of the study - July/August 2020 (planned)
4. Results of the study - ESOC November 2020

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

01/08/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/05/2020: Trial's existence confirmed by Ethics Committee of University Hospital Zagreb.