Evaluation of the Effect of Early Administration of Neuroprotective Drug (Cerebrolysin) on the Outcome of Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- pre MRS
Study Overview
Brief Summary
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
Detailed Description
Introduction:
Acute ischemic stroke is one of the main leading cause of death and disability in the world. In proposed project we evaluate the impact of the combination of early reperfusion therapy (thrombectomy) with early neuroproptective drug administration on treatment results in patients with acute ischemic stroke. Cerebrolysin, which has been shown to have neuroprotective and neurotrophic effects in vitro and in vivo, when administered early in combination with early endovascular therapy may have a positive effect on the prognosis and treatment outcomes of these patients. The proposed study, is approved by the Pomeranian Medical University Bioethics Committee in Szczecin, Poland, will be also part of the international CERECAP project investigating the co-application of neuroprotective and reperfusion therapies (thrombolysis, thrombectomy) in patients with acute ischemic stroke.
Purpose of the project:
examining the impact of early cerebrolysin supply on the treatment effect in patients with diagnosed acute ischemic stroke, qualified for endovascular treatment in the form of thrombectomy
Hypothesis:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •acute ischemic stroke diagnosis,
- •qualification for mechanical thrombectomy, without previous thrombolysis
Exclusion Criteria
- •pregnancy
- •cerebrolysin allergy
- •renal failure
- •thrombolysis
Arms & Interventions
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.
Intervention: Cerebrolysin (Drug)
Outcomes
Primary Outcomes
pre MRS
Time Frame: month 6
modified pre Rankin Score
IV
Time Frame: 10 days
infarct volume of the control CT
Survival
Time Frame: 6 months
survival rate within first 6 months
NIHSS
Time Frame: month 6
NIH Stroke Scale
IQ code
Time Frame: month 6
IQ code
Geriatric Depression Scales
Time Frame: month 6
Geriatric Depression Scales
Rankin
Time Frame: month 6
modified Rankin Score
modified treatment in cerebral infarction (mTICI score)
Time Frame: 1 month
measure the reperfusion grade post thrombectomy - radiological imaging
Secondary Outcomes
No secondary outcomes reported
Investigators
Klaudyna Kojder
Principal Investigator
Pomeranian Medical University Szczecin