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Cerebrolysin REGistry Study in Stroke (CREGS-S)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02541227
Recruitment Status : Terminated (The goal to match 1000 patients per group could not be achieved with reasonable effort and in reasonable time.)
First Posted : September 4, 2015
Last Update Posted : April 6, 2022
Sponsor:
Collaborator:
SITS International
Information provided by (Responsible Party):
Ever Neuro Pharma GmbH

Brief Summary:
Investigation of clinical practices, safety and effectiveness of Cerebrolysin in routine treatment of patients with acute ischemic stroke.

Condition or disease Intervention/treatment
Ischemic Stroke Drug: Cerebrolysin

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1823 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
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
Study Start Date : May 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

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
Drug: Cerebrolysin
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)


  2. Montreal Cognitive Assessment (MoCA) [ Time Frame: 90 days ]
    Ordinal MoCA assessment of cognitive functions at 3 months after stroke

  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients receive acute ishemic stroke care according to local treatment standards, not amended or influenced by the study
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541227


Locations
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Austria
AKH Linz
Linz, Austria, 4024
Sponsors and Collaborators
Ever Neuro Pharma GmbH
SITS International
Investigators
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Study Chair: Kennedy Lees, MD University of Glasgow
Additional Information:

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Responsible Party: Ever Neuro Pharma GmbH
ClinicalTrials.gov Identifier: NCT02541227    
Other Study ID Numbers: EVER-GB-0514
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: March 2022
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrolysin
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Nootropic Agents