A registry study to observe clinical practices, safety and effectiveness of routine use of Cerebrolysin in the treatment of patients with moderate to severe neurological deficits after acute ischaemic stroke
| ISRCTN | ISRCTN98553245 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98553245 |
| ClinicalTrials.gov number | NCT03480698 |
| Secondary identifying numbers | EVER-AT-0717 |
- Submission date
- 06/04/2021
- Registration date
- 27/04/2021
- Last edited
- 12/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Stroke is a devastating disease and one of the primary causes for death and long-term morbidity imposing a heavy burden on patients, relatives and the health care system. Except for fibrinolytic therapy, which is only possible in a minor fraction of patients, there is no widely approved medication for the treatment of acute stroke.
Cerebrolysin has been approved for the treatment of stroke in over 45 countries worldwide.
Since the approval of Cerebrolysin, stroke therapy has evolved, namely, with improved overall care, stroke units, more targeted rehabilitation, and the increasing availability of fibrinolytic therapy (rtPA, Actilyse) in specialized centers throughout the world. More recently, interventional therapies with various thrombus retrievers have emerged.
In addition, the Cerebrolysin treatment in stroke has evolved with different time windows, dosages and lengths of therapy being given in a pragmatic way by physicians within the specification of Product Characteristics for Cerebrolysin (SPC).
The main aim of this study is to systematically record Cerebrolysin treatment modalities and concomitant medication, according to local standards, in patients with moderate to severe neurological deficits after acute ischemic stroke and to assess the impact of these parameters on therapy outcome during early rehabilitation (day 21) and on day 90.
Besides this, the effectiveness and safety of Cerebrolysin therapy are monitored against the background of the now established and evolving stroke therapies (rtPA, thrombectomy). Furthermore, the effectiveness and safety of Cerebrolysin will be evaluated according to pre-existing diseases, concomitant medication and to applied rehabilitative actions. In the concomitant control group, these therapies alone or in combination will be compared to the addition of Cerebrolysin in these patients. Of interest is also the treatment in stroke units, with rtPA and systematic rehabilitation until day 21 and day 90.
An open observational treatment design has been chosen to collect data to capture the therapies as applied in real clinical practice. The pre-specified strategy follows the recommendations of the Principles for Good Research on Comparative Effectiveness (GRACE). A two-stage procedure is planned (Stage I: about 670 patients, Stage II: about 1400 patients).
Who can participate?
Patients aged 18 years or older, with clinical diagnosis of acute ischemic stroke, confirmed by imaging, no prior stroke, no prior disability.
What does the study involve?
All patients receive acute stroke care according to local treatment standards, which will not be amended or influenced by the study in any way. To evaluate the safety and effectiveness of Cerebrolysin in routine practice the outcome of Cerebrolysin-treated patients are compared with control group patients, who do not receive Cerebrolysin.
What are the possible benefits and risks of participating?
As this is a non-interventional study there are no additional treatments or evaluations. All patients receive acute stroke care according to local treatment standards, which will not be amended or influenced by the study. Patients are invited for two follow-up visits (day 21 and day 90) to evaluate and discuss the current status or their well-being. It is possible that a patient will receive Cerebrolysin according to treating physician’s choice. Cerebrolysin might help to limit neurological deficits after stroke and enhance recovery.
The information obtained from this study will be helpful for the optimization and further research in the treatment of patients suffering from stroke.
There is no potential risk by participation in the study, the routine treatment will not be changed in any way.
Where is the study run from?
EVER Neuro Pharma (Austria)
When is the study starting and how long is it expected to run for?
February 2017 to May 2024
Who is funding the study?
EVER Neuro Pharma (Austria)
Who is the main contact?
Dr Marion Jech, marion.jech@everpharma.com
Contact information
Public
Oberburgau 3
Unterach
4866
Austria
| Phone | +43 (0)766520555 |
|---|---|
| marion.jech@everpharma.com |
Study information
| Study design | Prospective non-interventional registry study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Registry study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Cerebrolysin REGistry Study in Stroke- a High-quality Observational Study of Comparative Effectiveness |
| Study acronym | C-REGS2 |
| Study hypothesis | This study investigates the clinical practices, safety and effectiveness of Cerebrolysin in routine treatment of patients with moderate to severe neurological deficits after acute ischemic stroke. The study takes place because real-world data for the use of Cerebrolysin is needed. |
| Ethics approval(s) |
Approved 23/01/2018, Ethikkommission des Landes Oberösterreich (Ethics Committee of Upper Austria, Wagner Jauregg Weg15, Linz, 4021, Austria; +42 (0)5 768087 Ext: 28631; ethikkommission.ooe@kepleruniklinikum.at), ref: 1026/2017 |
| Condition | Acute stroke |
| Intervention | Standard stroke care is compared to standard stroke care and Cerebrolysin as add-on. All patients receive acute stroke care according to local treatment standards, which will not be amended or influenced by the study in any way. To evaluate the safety and effectiveness of Cerebrolysin in routine practice the outcome of Cerebrolysin-treated patients are compared with control group patients, who do not receive Cerebrolysin. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cerebrolysin |
| Primary outcome measure | Neurologic disability measured using the modified Rankin Scale (mRS) at 3 months after stroke onset |
| Secondary outcome measures | 1. Stroke severity measured using NIH Stroke Scale (NIHSS) at 21 days and 3 months after stroke onset 2. Neurologic disability measured using modified Rankin Scale (mRS) at 21 days after stroke onset 3. Cognitive impairment measured using Montreal - Cognitive Assessment (MoCA) at 3 months after stroke |
| Overall study start date | 01/02/2017 |
| Overall study end date | 15/05/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2,000 |
| Total final enrolment | 1851 |
| Participant inclusion criteria | 1. Signed informed consent 2. Clinical diagnosis of acute ischemic stroke confirmed by imaging 3. Moderate to severe neurological deficits with NIH Stroke Scale (NIHSS) 8 to 15, both inclusive 4. No prior stroke 5. No prior disability 6. Patient's independence prior to stroke onset (pre-morbid mRS of 0 or 1) 7. Reasonable expectation of successful follow-up (max. 100 days) |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 25/04/2018 |
| Recruitment end date | 31/12/2023 |
Locations
Countries of recruitment
- Austria
- Korea, South
- Mexico
- Philippines
- Poland
- Romania
- Russian Federation
- Ukraine
- Viet Nam
Study participating centres
Krankenhausstraße 9
Linz
4020
Austria
Alter Ziegelweg 10
Tulln
3430
Austria
Krankenhausstraße 21
Amstetten
3300
Austria
Anichstraße 35
Innsbruck
6020
Austria
Ignaz-Harrer-Straße 79
Salzburg
5020
Austria
Sejong
30099
Korea, South
Daegu
42472
Korea, South
Toriello Guerra
Tlalpan
Ciudad de Mexico
14140
Mexico
Timișoara
300723
Romania
143200
Russian Federation
355029
Russian Federation
04107
Ukraine
21037
Ukraine
Thái Nguyên
unkn.
Viet Nam
Wałcz
78-600
Poland
Warszawa
02-957
Poland
Cebu City
6000
Philippines
Quezon City
1112
Philippines
Sponsor information
Industry
Oberburgau 3
Unterach
4866
Austria
| Phone | +43 (0)7665205550 |
|---|---|
| office@everpharma.com | |
| Website | http://www.everpharma.com/ |
"ROR" |
https://ror.org/032900178 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- EVER Pharma, EVER Neuro Pharma GmbH
- Location
- Austria
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Name and email: Marion Jech marion.jech@everpharma.com Type of data: hardlocked patient level analysis data When and how long available: at time of publication, for 5 years Access: password protected link Shared with whom: academic or governmental institutions For what type of analyses: re-analysis based on preplanned SAP methodology Consent of participants obtained: Any patient identifiers as well as country- and site-specific information will be removed for full data anonymisation |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version v3.3 | 01/03/2021 | 04/05/2021 | No | No |
| Statistical Analysis Plan | version v1 | 24/10/2017 | 04/05/2021 | No | No |
| Statistical Analysis Plan | version 1.1 | 22/07/2024 | 12/09/2024 | No | No |
Additional files
- ISRCTN98553245_PROTOCOL_v3.3_1Mar2021.pdf
- uploaded 04/05/2021
- ISRCTN98553245_SAP_v1_24Oct2017.pdf
- uploaded 04/05/2021
- ISRCTN98553245C-REGS_2_SAP_v1.1 22Jul2024.pdf
Editorial Notes
12/09/2024: The statistical analysis plan v1.1 was uploaded as an additional file.
09/04/2024: The overall study end date was changed from 15/04/2024 to 15/05/2024.
04/03/2024: The following changes were made to the trial record:
1. The overall study end date was changed from 31/03/2024 to 15/04/2024.
2. The total final enrolment was added.
3. The intention to publish date was changed from 30/09/2024 to 30/06/2025.
02/11/2023: The overall end date was changed from 31/12/2023 to 31/03/2024.
04/05/2021: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file. Version 3.3, 1 March 2021.
2. The statistical analysis plan was uploaded as an additional file.
22/04/2021: Trial's existence confirmed by Ethikkommission des Landes Oberösterreich.
