Stroke, Acute, IschemicPhase 2/3NCT05124353
Early Administration of Cerebrolysin on the Outcome of Patients With Acute Stroke Undergoing EVT
A Phase 2/3 study testing Cerebrolysin in people with Stroke, Acute, Ischemic, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Ischemic
- What is being tested?
- Cerebrolysin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 27 Apr 2021to 1 Apr 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute ischemic stroke diagnosis,
- qualification for mechanical thrombectomy, without previous thrombolysis
- age >18
Who cannot join
- age <18
- pregnancy
- cerebrolysin allergy
- epilepsy
- renal failure
- thrombolysis
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Pomeranian Medical University, University Hospital no.1
Szczecin
Klaudyna Kojder, +48692581426 ext. +48, klaudynakojder@gmail.com
Klaudyna Kojder, klaudynakojder@gmail.com
About this study
Official title: Evaluation of the Effect of Early Administration of Neuroprotective Drug (Cerebrolysin) on the Outcome of Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy
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.
Read more
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
Read the 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
- Conditions
- Stroke, Acute, Ischemic
- Being tested
- Cerebrolysin
- Keywords
- acute.stroke, ischemic stroke, neuroprotection, treatment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerebrolysinDrug
Also called neuroprotective treatment
Cerebrolysin 30ml i.v., administrated in first 6 hours after stroke onset and fo 10 day afterwards in Neurology Department or ICU conditions.
| Study group | Role | What they receive |
|---|---|---|
| G1 : Treatment Group (TG)r | Active comparator | 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. Receives: Drug: Cerebrolysin |
| G2 : Control Group (CG) | No intervention | Patients in CG receive no additional i.v. treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
survival rate within first 6 months
Measured: 6 months
NIHSS
NIH Stroke Scale
Measured: day 1
NIHSS
NIH Stroke Scale
Measured: month 3
NIHSS
NIH Stroke Scale
Measured: month 6
Rankin
modified Rankin Score
Measured: day 1
Rankin
modified Rankin Score
Measured: month 3
Rankin
modified Rankin Score
Measured: month 6
pre MRS
modified pre Rankin Score
Measured: day 1
pre MRS
modified pre Rankin Score
Measured: month 3
pre MRS
modified pre Rankin Score
Measured: month 6
IQ code
IQ code
Measured: month 3
IQ code
IQ code
Measured: month 6
Geriatric Depression Scales
Geriatric Depression Scales
Measured: month 3
Geriatric Depression Scales
Geriatric Depression Scales
Measured: month 6
IV
infarct volume of the control CT
Measured: 10 days
modified treatment in cerebral infarction (mTICI score)
measure the reperfusion grade post thrombectomy - radiological imaging
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start27 Apr 2021
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, Acute, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaudyna Kojder, Pomeranian Medical University Szczecin
- Investigators
- Konrad Jarosz, Principal investigator, Pomeranian Medical Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124353
- Sponsor's protocol ID
- Neuroprotective 1/2021
- Status last verified
- Nov 2021
- First submitted
- 25 Jun 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Early Administration of Neuroprotective Drug (Cerebrolysin) on the Outcome of Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy
- ClinicalTrials.gov ID
- NCT05124353
- Acronym / sponsor ID
- Neuroprotective 1/2021
- Conditions
- Stroke, Acute, Ischemic
- Keywords
- acute.stroke, ischemic stroke, neuroprotection, treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G1 : Treatment Group (TG)r | Active comparator | Drug: CerebrolysinPatients 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. |
| G2 : Control Group (CG) | No intervention | –Patients in CG receive no additional i.v. treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- acute ischemic stroke diagnosis,
- qualification for mechanical thrombectomy, without previous thrombolysis
- age >18
Key exclusion criteria (6 listed)
- age <18
- pregnancy
- cerebrolysin allergy
- epilepsy
- renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CerebrolysinAlso: neuroprotective treatmentCerebrolysin 30ml i.v., administrated in first 6 hours after stroke onset and fo 10 day afterwards in Neurology Department or ICU conditions. | Drug | G1 : Treatment Group (TG)r |
Primary outcome
Survival
Time frame: 6 months
survival rate within first 6 months
NIHSS
Time frame: day 1
NIH Stroke Scale
NIHSS
Time frame: month 3
NIH Stroke Scale
NIHSS
Time frame: month 6
NIH Stroke Scale
Rankin
Time frame: day 1
modified Rankin Score
Rankin
Time frame: month 3
modified Rankin Score
Rankin
Time frame: month 6
modified Rankin Score
pre MRS
Time frame: day 1
modified pre Rankin Score
pre MRS
Time frame: month 3
modified pre Rankin Score
pre MRS
Time frame: month 6
modified pre Rankin Score
IQ code
Time frame: month 3
IQ code
IQ code
Time frame: month 6
IQ code
Geriatric Depression Scales
Time frame: month 3
Geriatric Depression Scales
Geriatric Depression Scales
Time frame: month 6
Geriatric Depression Scales
IV
Time frame: 10 days
infarct volume of the control CT
modified treatment in cerebral infarction (mTICI score)
Time frame: 1 month
measure the reperfusion grade post thrombectomy - radiological imaging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konrad Jarosz principal investigator
Pomeranian Medical Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cerebrolysin in people with Stroke, Acute, Ischemic, run by Pomeranian Medical University Szczecin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Klaudyna Kojder (+48692581426 ext. +48, klaudynakojder@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 6 months). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.