Evaluation of efficacy and safety of Cerebrolysin as add-on therapy in patients with acute stroke after failed recanalisation therapy
| ISRCTN | ISRCTN15233803 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15233803 |
| Secondary identifying numbers | EP - 43/17 |
- Submission date
- 04/05/2020
- Registration date
- 25/05/2020
- Last edited
- 14/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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
Contact information
Scientific
Principal Investigator
University Hospital Centre Zagreb
Kispaticeva 12, Dept. of Neurology
Zagreb
10000
Croatia
| Phone | +385 (0)12388341 |
|---|---|
| zpoljako@kbc-zagreb.hr |
Study information
| Study design | Interventional non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study acronym | CEREC-Stroke |
| Study hypothesis | Cerebrolysin therapy in patients with acute severe stroke after failed reperfusion therapy improves outcome. |
| Ethics approval(s) | 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 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/08/2017 |
| Overall study end date | 01/01/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 46 |
| 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 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
Study participating centre
Kispaticeva 12
Zagreb
10000
Croatia
Sponsor information
Hospital/treatment centre
Dept. of Neurology
Kispaticeva 12
Zagreb
10000
Croatia
| Phone | +385 (0)12388341 |
|---|---|
| zdravka.po@gmail.com | |
| Website | https://www.kbc-zagreb.hr/ |
"ROR" |
https://ror.org/00r9vb833 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/08/2021 | 16/08/2021 | Yes | No | |
| Abstract results | 01/09/2021 | 14/06/2023 | No | No |
Editorial Notes
14/06/2023: Abstract added.
16/08/2021: Publication reference added.
12/05/2020: Trial's existence confirmed by Ethics Committee of University Hospital Zagreb.
