NCT02541227

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,823

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

3.6 years

First QC Date

August 28, 2015

Last Update Submit

March 28, 2022

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Scale

    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.

    90 days

Secondary Outcomes (3)

  • The National Institutes of Health Stroke Scale (NIHSS)

    90 days

  • Montreal Cognitive Assessment (MoCA)

    90 days

  • 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

Study Arms (2)

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

Control group

Patients who are not treated with Cerebrolysin; treatment follows local clinical practice

Interventions

CerebrolysinDRUG

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

Cerebrolysin group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AKH Linz

Linz, 4024, Austria

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

cerebrolysin

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kennedy Lees, MD

    University of Glasgow

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2015

First Posted

September 4, 2015

Study Start

May 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2021

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations

AU(1)