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

Phase 2

• Conditions: Stroke, Acute, Ischemic
• Interventions: Drug: Cerebrolysin

• Registration Number: NCT05124353
• Lead Sponsor: Pomeranian Medical University Szczecin

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:

Cerebrolysin in early (up do 6 h) administration with combination of early (up to 6h) endovascular therapy (thrombectomy) is beneficial for the patients with acute ischemic stroke diagnosis.

Material and method 100 patients will be qualified for the proposed project. Study duration: 24 months.

Inclusion criteria for the study diagnosis of acute ischemic stroke qualification for endovascular treatment in the form of thrombectomy

Criteria for exclusion from the study:

Patient qualified for thrombolysis Patients under 18 years of age pregnancy Kidney failure Epilepsy History of allergy to cerebrolysin

Study design:

After prior randomization to the group, patients will be divided into group G1 (cerebrolysin supply) and group G2 (standard treatment, without cerebrolysin supply).

In group G1, cerebrolysin will be administered immediately after qualifying for the study (i.e. up to 6 hours after the onset of symptoms) and continued for the next 10 days at a dose of 30 ml i.v.

Patients from both groups G1 and G2 will undergo thrombectomy treatment, and then, depending on the clinical condition, hospitalized in the Intensive Care Unit or the Department of Neurology with the Stroke Department.

During the hospitalization, the standard and typical care for both departments will be continued.

Treatment results will be assessed using:

NIH, Modified Rankin Scale, preMRS, IQ code, Geriatric Depression Scale and MoCA.

Routine checkups for computed tomography will also undergo analysis for treatment evaluation (e.g. stroke volume). Patients' condition will be assessed after 1, 3 and 6 months.

The results obtained in this way will be statistically analyzed and presented in the form of articles in medical journals.

Expected benefits:

* examination of the influence of early cerebrolysin supply on the treatment effect in patients undergoing thrombectomy after acute ischemic stroke diagnosis

* development of the cerebrolysin supply protocol in patients with acute ischemic stroke diagnosis

Study Timeline

• Study Start: 2021-04-27
• Study First Submitted: 2021-06-25
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-07
• Last Update Submitted: 2021-11-07
• Study First Posted: 2021-11-17
• Last Update Posted: 2021-11-17
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G1 : Treatment Group (TG)r	Cerebrolysin	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.

Primary Outcome Measures

Name	Time	Method
pre MRS	month 6	modified pre Rankin Score
Survival	6 months	survival rate within first 6 months
NIHSS	month 6	NIH Stroke Scale
IQ code	month 6	IQ code
Geriatric Depression Scales	month 6	Geriatric Depression Scales
IV	10 days	infarct volume of the control CT
Rankin	month 6	modified Rankin Score
modified treatment in cerebral infarction (mTICI score)	1 month	measure the reperfusion grade post thrombectomy - radiological imaging

Trial Locations

Locations (1)

Pomeranian Medical University, University Hospital no.1; 🇵🇱 Szczecin, Poland