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Trial · Interventional

Status unknownPhase 2/3Registry data

Early Administration of Cerebrolysin on the Outcome of Patients With Acute Stroke Undergoing EVT

NCTNCT05124353 (opens ClinicalTrials.gov in a new tab)Other idNeuroprotective 1/2021
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 2/3
Enrollment
100 participants (estimated)
Sponsor
Pomeranian Medical University Szczecin · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Poland

Start
27 Apr 2021
Primary completion
1 Apr 2023 (estimated)
Completion
1 Apr 2023 (estimated)
First posted
17 Nov 2021
Last update posted
17 Nov 2021
Conditions
Stroke, Acute, Ischemic

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph 2/3

    Early Administration of Cerebrolysin on the Outcome of Patients With Acute Stroke Undergoing EVT

    NCT05124353

    27 Apr 2021 to est. 1 Apr 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Background: Stroke is the third major cause of death and disability worldwide. It was shown that combining early reperfusion therapy (thrombolysis and/or thrombectomy) with stroke unit care and immediate rehabilitation have beneficial effects on the patient recovery and outcomes. Cerebrolysin that was proven to have s neuroprotective and neurotrophic effects in vitro and in vivo, administered in combination with endovascular therapy (EVT) could have a positive impact on the prognosis and outcome of these patients. Objectives: To evaluate the impact of early administration of neuroprotective drug (Cerebrolysin) in patient undergoing EVT on the outcome of patients diagnosed with acute ischemic stroke. Methods: 100 patients will be recruited to the proposed study according to the inclusion criteria: Inclusion criteria: Acute ischemic stroke patients NIHSS\>8 Qualification for mechanical thrombectomy, without previous thrombolysis. The patients will be randomized into 2 subgroups: G1(standard dose of Cerebrolysin 30ml), - G2 (No Cerebrolysin). The patients will be randomized into 2 subgroups: G1(standard dose of Cerebrolysin 30ml), - G2 (No Cerebrolysin). Cerebrolysin will be administered immediately after randomization or at the latest during the EVT procedure and will be continued for 10 days. After the EVT all patients, depending on their clinical condition, will be hospitalized in ICU (intensive care unit) or Neurology Department, where standard treatment and monitoring will be implemented, as well as standard rehabilitation. Outcome assessments will include: the NIH Stroke Scale, modified Rankin Score, pre MRS, IQ code, Geriatric Depression Scales, MoCA. Additionally, the infarct volume of the control CT will be measured. The follow up should be performed on day 7( or discharge), 1 month, 3 months, 6 months. The duration of the study is planned forr: 12 -24 months

Interventions

  • CerebrolysinDrug

Arms2

  • Active comparator

    G1 : Treatment Group (TG)r

    Patients in TG receive neuroprotective drug: standard dose of Cerebrolysin 30ml i.v. in the first 6 hours after first symptoms. After EVT the administration is continued for 10 days.

  • No intervention

    G2 : Control Group (CG)

    Patients in CG receive no additional i.v. treatment.

Primary outcomes16

Outcomes the sponsor listed as primary.

  1. Survival

    Time frame · 6 months

    Registry description

    survival rate within first 6 months

  2. NIHSS

    Time frame · day 1

    Registry description

    NIH Stroke Scale

  3. NIHSS

    Time frame · month 3

    Registry description

    NIH Stroke Scale

  4. NIHSS

    Time frame · month 6

    Registry description

    NIH Stroke Scale

  5. Rankin

    Time frame · day 1

    Registry description

    modified Rankin Score

  6. Rankin

    Time frame · month 3

    Registry description

    modified Rankin Score

  7. Rankin

    Time frame · month 6

    Registry description

    modified Rankin Score

  8. pre MRS

    Time frame · day 1

    Registry description

    modified pre Rankin Score

  9. pre MRS

    Time frame · month 3

    Registry description

    modified pre Rankin Score

  10. pre MRS

    Time frame · month 6

    Registry description

    modified pre Rankin Score

  11. IQ code

    Time frame · month 3

    Registry description

    IQ code

  12. IQ code

    Time frame · month 6

    Registry description

    IQ code

  13. Geriatric Depression Scales

    Time frame · month 3

    Registry description

    Geriatric Depression Scales

  14. Geriatric Depression Scales

    Time frame · month 6

    Registry description

    Geriatric Depression Scales

  15. IV

    Time frame · 10 days

    Registry description

    infarct volume of the control CT

  16. modified treatment in cerebral infarction (mTICI score)

    Time frame · 1 month

    Registry description

    measure the reperfusion grade post thrombectomy - radiological imaging

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * acute ischemic stroke diagnosis, * qualification for mechanical thrombectomy, without previous thrombolysis * age \>18 Exclusion Criteria: * age \<18 * pregnancy * cerebrolysin allergy * epilepsy * renal failure * thrombolysis

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