Ischemic StrokeCREGS-SNCT02541227
Cerebrolysin REGistry Study in Stroke
An observational study of Ischemic Stroke, run by Ever Neuro Pharma GmbH at 1 site in Austria.
Trial summary
Investigation of clinical practices, safety and effectiveness of Cerebrolysin in routine treatment of patients with acute ischemic stroke. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Cerebrolysin
- How many people
- 1,823 participants
- Where
- 1 siteAustria
- Study dates
- May 2014to Dec 2021
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients receive acute ishemic stroke care according to local treatment standards, not amended or influenced by the study
Who may be able to join
- Signed informed consent
- Clinical diagnosis of acute ischemic stroke
- Patient's independence prior to stroke onset (pre-morbid mRS of 0 or 1)
- Reasonable expectation of successful follow-up (max. 100 days)
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebrolysin REGistry Study in Stroke A Registry Study to Assess Practices, Safety and Effectiveness of Cerebrolysin in Routine Treatment of Acute Ischemic Stroke
Investigation of clinical practices, safety and effectiveness of Cerebrolysin in routine treatment of patients with acute ischemic stroke.
Read the detailed description
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 capture these variables of the Cerebrolysin treatment and its comedication in order to give guidance to further research. This research may consist of an extension of the current registry or targeted research in one or several subgroups of patients responding to Cerebrolysin treatment.
It is therefore the overall aim of this registry study to monitor the effectiveness and safety of Cerebrolysin therapy against the background of the now established and evolving stroke therapies. In the concomitant control group these therapies alone or in combination will be compared to the addition of Cerebrolysin in these patients. Of particular interest is the treatment in stroke units, with rtPA and systematic rehabilitation.
An open observational treatment design has been chosen to collect data to capture the therapies as applied in real clinical practice and to avoid the selection bias typical for controlled studies excluding the majority of patients from participation. In order to overcome the observational bias as major and inherent limitation of open trial designs, a remote and blinded assessment will be done: after three months treatment the patients' assessment of the modified Rankin Scale (mRS, a widely accepted primary outcome parameter) will be -after specific informed consent- video-taped and subsequently assessed by at least two independent and blinded assessors experienced in the remote assessment of the mRS.
- Conditions
- Ischemic Stroke
- Being tested
- Cerebrolysin
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerebrolysinDrug
Cerebrolysin dosage, frequency and duration follows local clinical practice in accordance with the terms of the local marketing authorization
| Study group | Role | What they receive |
|---|---|---|
| Cerebrolysin group | Patients who are treated with Cerebrolysin; dosage, frequency and duration follows local clinical practice in accordance with the terms of the local marketing authorization Receives: Drug: Cerebrolysin | |
| Control group | Patients who are not treated with Cerebrolysin; treatment follows local clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale
Ordinal analysis of the mRS on day 90 was chosen as statistically powerful primary endpoint, as it is robust to case mix, clinically relevant and treatment-responsive.
Measured: 90 days
Secondary outcomes (3)
The National Institutes of Health Stroke Scale (NIHSS)
Ordinal NIHSS at 3 months after stroke onset
- Home Time (number of nights among the first 90 days after stroke onset that the patient spends in his own or a relative's private home)
Measured: 90 days
Montreal Cognitive Assessment (MoCA)
Ordinal MoCA assessment of cognitive functions at 3 months after stroke
Measured: 90 days
Home Time (number of nights among the first 90 days after stroke onset that the patient spends in his own or a relative's private home)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startMay 2014
- Primary completionDec 2017
- Study completionDec 2021
Why it stopped: The goal to match 1000 patients per group could not be achieved with reasonable effort and in reasonable time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,823 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Ever Neuro Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SITS International
- Responsible party
- Sponsor
- Investigators
- Kennedy Lees, MD, Study chair, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541227
- Sponsor's protocol ID
- EVER-GB-0514
- Acronym
- CREGS-S
- Status last verified
- Mar 2022
- First submitted
- 28 Aug 2015
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrolysin REGistry Study in Stroke A Registry Study to Assess Practices, Safety and Effectiveness of Cerebrolysin in Routine Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02541227
- Acronym / sponsor ID
- CREGS-S / EVER-GB-0514
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The goal to match 1000 patients per group could not be achieved with reasonable effort and in reasonable time.
- Enrolment
- 1,823 participants (actual)
- Lead sponsor
- Ever Neuro Pharma GmbHIndustry (pharma, biotech, devices)
- Collaborators
- SITS International
- Study start
- May 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of clinical practices, safety and effectiveness of Cerebrolysin in routine treatment of patients with acute ischemic stroke.
Detailed description
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 capture these variables of the Cerebrolysin treatment and its comedication in order to give guidance to further research. This research may consist of an extension of the current registry or targeted research in one or several subgroups of patients responding to Cerebrolysin treatment.
It is therefore the overall aim of this registry study to monitor the effectiveness and safety of Cerebrolysin therapy against the background of the now established and evolving stroke therapies. In the concomitant control group these therapies alone or in combination will be compared to the addition of Cerebrolysin in these patients. Of particular interest is the treatment in stroke units, with rtPA and systematic rehabilitation.
An open observational treatment design has been chosen to collect data to capture the therapies as applied in real clinical practice and to avoid the selection bias typical for controlled studies excluding the majority of patients from participation. In order to overcome the observational bias as major and inherent limitation of open trial designs, a remote and blinded assessment will be done: after three months treatment the patients' assessment of the modified Rankin Scale (mRS, a widely accepted primary outcome parameter) will be -after specific informed consent- video-taped and subsequently assessed by at least two independent and blinded assessors experienced in the remote assessment of the mRS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebrolysin group | – | Drug: CerebrolysinPatients who are treated with Cerebrolysin; dosage, frequency and duration follows local clinical practice in accordance with the terms of the local marketing authorization |
| Control group | – | –Patients who are not treated with Cerebrolysin; treatment follows local clinical practice |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients receive acute ishemic stroke care according to local treatment standards, not amended or influenced by the study
Key inclusion criteria (4 listed)
- Signed informed consent
- Clinical diagnosis of acute ischemic stroke
- Patient's independence prior to stroke onset (pre-morbid mRS of 0 or 1)
- Reasonable expectation of successful follow-up (max. 100 days)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CerebrolysinCerebrolysin dosage, frequency and duration follows local clinical practice in accordance with the terms of the local marketing authorization | Drug | Cerebrolysin group |
Primary outcome
Modified Rankin Scale
Time frame: 90 days
Ordinal analysis of the mRS on day 90 was chosen as statistically powerful primary endpoint, as it is robust to case mix, clinically relevant and treatment-responsive.
3 secondary outcomes
The National Institutes of Health Stroke Scale (NIHSS)
Time frame: 90 days
Montreal Cognitive Assessment (MoCA)
Time frame: 90 days
Home Time (number of nights among the first 90 days after stroke onset that the patient spends in his own or a relative's private home)
Time frame: 90 days
Results and safety
The study was stopped early (reason given: The goal to match 1000 patients per group could not be achieved with reasonable effort and in reasonable time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kennedy Lees, MD study chair
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Ever Neuro Pharma GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The goal to match 1000 patients per group could not be achieved with reasonable effort and in reasonable time.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.