Cerebrolysin REGistry Study in Stroke - a High-quality Observational Study of Comparative Effectiveness (C-REGS2)

Ever Neuro Pharma

Status

Completed

Conditions

Acute Ischemic Stroke

Treatments

Drug: Cerebrolysin

Study type

Observational

Funder types

Industry

Other

Identifiers

NCT03480698

EVER-AT0717

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,851 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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