Cerebrolysin REGistry Study in Stroke

NCT ID: NCT02541227

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1823 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2021-12-31

Brief Summary

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.

Conditions

Ischemic Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Intervention Type: DRUG

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

No interventions assigned to this group

Interventions

Cerebrolysin

Cerebrolysin dosage, frequency and duration follows local clinical practice in accordance with the terms of the local marketing authorization

Intervention Type: DRUG

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SITS International

NETWORK

Sponsor Role: collaborator

Ever Neuro Pharma GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kennedy Lees, MD

Role: STUDY_CHAIR

University of Glasgow

Locations

AKH Linz

Linz, , Austria

Countries

Austria

Other Identifiers

EVER-GB-0514

Identifier Type: -

Identifier Source: org_study_id