Clinical trial NCT03480698: Cerebrolysin REGistry Study in Stroke - a High-quality Observational Study of Comparative Effectiveness
Official title: C-REGS2 - a Registry Study to Observe Clinical Practices, Safety and Efficiency of Routine Use of Cerebrolysin in the Treatment of Patients with Moderate to Severe Neurological Deficits After Acute Ischaemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Keywords: acute ischemic stroke
Lead sponsor: Ever Neuro Pharma GmbH
Sponsor class: INDUSTRY
Collaborators: name: IDV Data analysis and study planning Dr. Rahlfs
First posted: 2018-03-29
Enrollment: 1851
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate to severe neurological deficits after acute ischemic stroke (NIHSS 8-15) at baseline

Brief summary: This study investigates the clinical practices, safety and effectiveness of Cerebrolysin in routine treatment of patients with moderate to severe neurological deficits after acute ischemic stroke.

Detailed description: Patients registered: Acute Ischemic Stroke patients with moderate to severe neurological deficits

All patients receive acute stroke care according to local treatment standards, not amended or influenced by the study:

Cerebrolysin Group:

Patients who are treated with Cerebrolysin; dosage, frequency and duration follows local clinical practice in accordance with terms of the local marketing authorization

Control group:

Patients who are not treated with Cerebrolysin

Observation criteria:

* Signed Informed Consent
* Clinical diagnosis of acute ischemic stroke confirmed by imaging
* Moderate to severe neurological deficits with NIH Stroke Scale (NIHSS) 8 to 15, both inclusive
* No prior stroke
* No prior disability
* Patient's independence prior to stroke onset (pre-morbid mRS of 0 or 1)
* Reasonable expectation of successful follow-up (max. 100 days)

The study follows the recommendations of the Principles for Good Research on Comparative Effectiveness (GRACE).

In order to comply with recent calls for high-quality non-interventional comparative effectiveness research, a risk-based centralized statistical approach to monitoring is introduced in combination with targeted on-site monitoring for ongoing surveillance of study conduct, thus ensuring highest standards of data quality and integrity according to the most recent requirements of the ICH E6 Guideline for Good Clinical Practice (GCP, Amendment R2, July 2015), the FDA Guidance for Industry on a Risk-based Approach to Monitoring, and the EMA reflection-paper on risk-based quality management in clinical trials.

Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* Clinical diagnosis of acute ischemic stroke confirmed by imaging
* Moderate to severe neurological deficits with NIH Stroke Scale (NIHSS) 8 to 15, both inclusive
* No prior stroke
* No prior disability
* 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

Primary outcomes:
measure: Ordinal modified Rankin Scale (mRS) at 3 months after stroke onset
timeFrame: 3 months
Secondary outcomes:
measure: Ordinal NIH Stroke Scale (NIHSS) at 21 days and 3 months after stroke onset
timeFrame: Day 21 and 3 months
measure: Ordinal modified Rankin Scale (mRS) at 21 days after stroke onset
timeFrame: 21 days
measure: Proportion of patients with excellent recovery (mRS score 0-1) at 3 months after stroke onset
timeFrame: 3 months
measure: Proportion of patients with functional independence (mRS score 0-2) at 3 months after stroke onset
timeFrame: 3 months
measure: Ordinal MoCA at 3 months after stroke
timeFrame: 3 months
Other outcomes:
Locations:
city: Amstetten
country: Austria
facility: Landesklinikum Amstetten
city: Eisenstadt
country: Austria
facility: Krankenhaus der Barmherzigen Brüder Eisenstadt
city: Innsbruck
country: Austria
facility: Universitätsklinik Innsbruck
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
city: Salzburg
country: Austria
facility: CDK Salzburg, Universitätsklinik für Neurologie
city: St. Pölten
country: Austria
facility: UK St. Pölten
city: Tulln
country: Austria
facility: UK Tulln
city: Wiener Neustadt
country: Austria
facility: LK Wiener Neustadt
Study officials:
affiliation: Danube University Krems - Head of the Department for Clinical Neuroscience and Preventive Medicine / Head of the Center for Neurosciences
name: Michael Brainin, Univ.-Prof. Dr.
role: STUDY_DIRECTOR
References: