- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02541227
Cerebrolysin REGistry Study in Stroke (CREGS-S)
Cerebrolysin REGistry Study in Stroke A Registry Study to Assess Practices, Safety and Effectiveness of Cerebrolysin in Routine Treatment of Acute Ischemic Stroke
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Linz, Austria, 4024
- AKH Linz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The National Institutes of Health Stroke Scale (NIHSS)
Time Frame: 90 days
|
Ordinal NIHSS at 3 months after stroke onset o 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) |
90 days
|
Montreal Cognitive Assessment (MoCA)
Time Frame: 90 days
|
Ordinal MoCA assessment of cognitive functions at 3 months after stroke
|
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
|
90 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Kennedy Lees, MD, University of Glasgow
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EVER-GB-0514
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ischemic Stroke
-
Nordsjaellands HospitalRigshospitalet, Denmark; Metropolitan University CollegeCompletedTransient Ischemic Attack | Stroke, Ischemic | Stroke HemorrhagicDenmark
-
University of CalgaryThe George Institute for Global Health, AustraliaNot yet recruitingAcute Ischemic Stroke AIS | Stroke, Acute, Stroke Ischemic | Stroke AcuteCanada, Australia
-
Second Affiliated Hospital, School of Medicine,...Shanghai Zhongshan Hospital; First Affiliated Hospital of Wenzhou Medical University and other collaboratorsRecruitingAcute Ischemic Stroke and Transient Ischemic AttacksChina
-
Medtronic Cardiac Rhythm and Heart FailureMedtronic Bakken Research CenterCompletedCryptogenic Symptomatic Transient Ischemic Attack | Cryptogenic Ischemic StrokeNetherlands, United States, France, Belgium, Germany, Sweden, Italy, Austria, Canada, Denmark, Finland, Greece, Slovakia, Spain
-
University Hospital, BrestCompletedStroke, Ischemic | Stroke HemorrhagicFrance
-
Umbria Bioengineering TechnologiesRecruitingStroke, Ischemic | Stroke HemorrhagicItaly
-
Sheffield Teaching Hospitals NHS Foundation TrustUnknownFatigue | Stroke, Ischemic | Stroke HemorrhagicUnited Kingdom
-
BayerRecruitingAcute Non-cardioembolic Ischemic Stroke | Prevention of Ischemic Stroke | High-risk Transient Ischemic AttackUnited States, Switzerland, Belgium, Sweden, Canada, Australia, Taiwan, Spain, Korea, Republic of, Latvia, Israel, Malaysia, Greece, Japan, Turkey, Netherlands, Romania, China, United Kingdom, Portugal, Italy, Brazil, France, Slovakia, ... and more
-
University of AlbertaCompletedTransient Ischemic Attack | Minor Ischemic StrokeCanada
-
Stephanie HarrisonActive, not recruitingTransient Ischemic Attack | Stroke, IschemicUnited Kingdom
Clinical Trials on Cerebrolysin
-
Ever Neuro Pharma GmbHacromion GmbHCompleted
-
Samsung Medical CenterCompletedCerebrolysinKorea, Republic of
-
Mansoura University Children HospitalCompleted
-
Kwong Wah HospitalCompletedSubarachnoid Hemorrhage | Delayed Cerebral Ischemia | Intracranial Aneurysm | Delayed Ischemic Neurological DeficitChina
-
Sahar M.A. Hassanein, MDCompletedHypoxic-Ischemic EncephalopathyEgypt
-
Clinical Institute of the Brain, RussiaUnknownIschemic StrokeRussian Federation
-
Ain Shams UniversityUnknownMental Handicap | Cerebral Palsy Children | Children With Traumatic Brain Injury | Delayed Speech DevelopmentEgypt
-
Mansoura University Children HospitalCompletedCerebral Palsy | Infant Development | Preterm InfantEgypt
-
Clinical Institute of the Brain, RussiaEver Neuro Pharma GmbH; Nycomed; VeropharmCompleted
-
Hospital Universitario Dr. Jose E. GonzalezEver Neuro Pharma GmbHRecruitingDiabetes Mellitus, Type 2 | Ischemic Stroke, Acute | Blood Brain BarrierMexico