Investigation of clinical practices, safety and effectiveness of Cerebrolysin in routine treatment of patients with acute ischemic stroke.
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.
- Cerebrolysin Drug
Intervention Desc: Cerebrolysin dosage, frequency and duration follows local clinical practice in accordance with the terms of the local marketing authorization ARM 1: Kind: Experimental Label: Cerebrolysin group Description: Patients who are treated with Cerebrolysin; dosage, frequency and duration follows local clinical practice in accordance with the terms of the local marketing authorization
- Observation: Cohort
- Perspective: Prospective
- Sampling: Probability Sample
All patients receive acute ishemic stroke care according to local treatment standards, not amended or influenced by the study
|Type||Measure||Time Frame||Safety Issue|
|Primary||Modified Rankin Scale||90 days||No|
|Secondary||The National Institutes of Health Stroke Scale (NIHSS)||90 days||No|
|Secondary||Montreal Cognitive Assessment (MoCA)||90 days||No|
|Secondary||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||No|