Acute Ischemic StrokePhase 4CERBERUSNCT06078215
CERebrolysine Effect on Blood-brain Barrier in acUte Ischemic Stroke
A Phase 4 study testing Cerebrolysin in people with Acute Ischemic Stroke, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
The study investigates whether Cerebrolysin stabilizes blood-brain barrier integrity in a manner that can be monitored using serum levels of the principal tight junction proteins, e.g., occludin (OCL), claudin-5 (CLN), and zonula occludens-1 (ZO-1), or other molecules known to be involved in BBB degradation, e.g.… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- 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
- 350 participants
- Where
- 1 sitePoland
- Study dates
- 10 Jan 2023to 31 Mar 2025
- Phase
- Phase 4
- 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 patients
- informed consent
Who cannot join
- no informed consent
- primary or metastatic brain tumor
- brain abscess
- encephalitis
- localized inflammation
- sepsis
Show all 10Show fewer
- autoimmune diseases of central or peripheral nervous system
- Cerebrolysin hypersensitivity / allergy
- epilepsy
- severe kidney disease
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
University Hospital
Poznan, 60-355
Slawomir Michalak, Prof., +4861 8691 535, swami@ump.edu.pl
Joanna Rybacka-Mossakowska, MD, PhD, +4861 8691 458, joannarybacka@gmail.com
About this study
Official title: CERebrolysine Effect on Blood-brain Barrier / Endothelium Integrity During Reperfusion Therapy of acUte Ischemic Stroke (CERBERUS Study)
The study investigates whether Cerebrolysin stabilizes blood-brain barrier integrity in a manner that can be monitored using serum levels of the principal tight junction proteins, e.g., occludin (OCL), claudin-5 (CLN), and zonula occludens-1 (ZO-1), or other molecules known to be involved in BBB degradation, e.g., S100B and whether it protects against hemorrhagic transformation in ischemic stroke patients after reperfusion therapy (i.e. thrombolysis and/or mechanical thrombectomy).
Read the detailed description
Hemorrhagic transformation (HT) of ischemic stroke can be identified in 3-40% of patients. The incidence varies depending on the definition used and the studied population. The severity of HT can be described using clinical and radiological tools and classified as asymptomatic/symptomatic, according to European Cooperative Acute Stroke Study classification and Heidelberg Bleeding Classification. Breakdown of the blood-brain barrier (BBB) is associated with an increased risk of developing a hemorrhagic transformation (HT) of ischemic stroke. In patients who received reperfusion therapy (thrombolysis, mechanical thrombectomy), secondary HT had a negative influence on the clinical course and outcome.
Tight junction (TJ) proteins are important cell adhesion components that stabilize endothelium cells lining and are responsible for maintaining the BBB integrity.
Biomarkers of BBB damage that can be evaluated during the early phases of stroke might be useful for predicting the risk of HT. Such biomarkers could also facilitate the decision of whether to begin thrombolytic therapy in acute ischemic stroke patients. Experimental data support the evidence for protective effect of Cerebrolysin on BBB integrity. Moreover, it diminished and reversed negative effect of recombinant tissue plasminogen activator (rtPA) used as thrombolytic agent on endothelial cells integrity. Cerebrolysin stabilized tight junction proteins expression: occludin, claudin-5 and zona occludens 1 (ZO1). In our previous study we have found that circulating TJs predict HT in ischemic stroke patients. Clinically evident HTs were associated with increased concentrations of occludin and S100B, an increase in the claudin-5/ZO-1 ratio, and a decreased level of vascular endothelial growth factor (VEGF). Claudin-5 levels also correlated with HT occurrence when estimated within 3 hours of stroke onset. The protective effects of Cerebrolysin were already clinically evidenced, however there are no available studies using biomarkers of BBB.
Aim of the study
We aim to investigate whether Cerebrolysin stabilizes BBB integrity in a manner that can be monitored using serum levels of the principal TJ proteins, e.g., occludin (OCL), claudin-5 (CLN), and zonula occludens-1 (ZO-1), or other molecules known to be involved in BBB degradation, e.g., S100B and whether it protects against HT in ischemic stroke patients after reperfusion therapy.
Study design
A prospective longitudinal study will be performed in ischemic stroke patients who:
- are included for reperfusion therapy (intravenous thrombolysis and/or mechanical thrombectomy - control (group A),
- are included for reperfusion therapy (intravenous thrombolysis and/or mechanical thrombectomy plus Cerebrolysin (group B)
- are not referred to reperfusion therapy nor Cerebrolysin (group C).
All patients with NIHSS score > 8 will receive 30 ml Cerebrolysin in 500 ml of buffered crystalloid solution intravenously initiated within 12 hours from symptoms onset.
Whole blood samples will be withdrawn at the admission, then within 1 to 3 days after stroke onset and at 7th day after stroke onset or when the endpoint will be reached by the patient. Occludin, claudin 5 and ZO-1 concentrations will be analyzed by means of home-made enzyme-linked immunosorbent assay.
Endpoint will include clinical worsening (increase in the NIHSS by > 4 points), radiologically evident hemorrhage or radiologically evident brain edema at control CT performed within 1 to 3 days after stroke onset.
Standard head CT will be performed in all patients at the admission, within 1 to 3 days after stroke onset, after worsening of clinical status and additionally when the differentiation between hemorrhage and contrast staining will be required in thrombectomy patients. Hemorrhagic transformation of ischemic stroke will be classified according to Table 1.
Clinimetric evaluation of all patients will include NIHSS every day for 7 days and at day 30. Modified Rankin scale (mRS) will be evaluated at visit 1,2,3,4 and 5; Barthel index at visit 4 and 5 and Montreal Cognitive Assessment Test at visit 5.
All patents will undergo current American Heart Association Guidelines for the Early Management of Patients with Acute Ischemic Stroke.
Expected results It is expected that Cerebrolysin can stabilize blood-brain barrier in ischemic stroke patients treated with reperfusion therapies via remodelling of tight junction proteins between endothelial cells. Such an effect measured by the levels of circulating tight junction proteins can translate into prevention of hemorrhagic transformation. To summarize, Cerebrolysine can guard blood-brain barrier integrity in ischemic stroke (Cerberus effect).
- Conditions
- Acute Ischemic Stroke
- Being tested
- Cerebrolysin
- Keywords
- Acute Ischemic Stroke, blood-brain barrier, cerebrolysin
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerebrolysinCombination product
Also called FPF (Fine Particle Fraction)-1070
Intravenous infusion of 30 ml Cerebrolysine in 500 ml of buffered crystalloid solution intravenously initiated within 12 hours from symptoms onset
| Study group | Role | What they receive |
|---|---|---|
| Thrombolysis and/or mechanical thrombectomy | No intervention | patients included for reperfusion therapy (intravenous thrombolysis and/or mechanical thrombectomy - comparator |
| Cerebrolysin | Experimental | patients included for reperfusion therapy (intravenous thrombolysis and/or mechanical thrombectomy and treated with Cerebrolysin Receives: Combination Product: Cerebrolysin |
| No reperfusion therapy / no cerebrolysin | No intervention | patients not referred to reperfusion therapy nor Cerebrolysin |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institute of Health Stroke Scale
National Institute of Health Stroke Scale; score range: 1-42; 1-4 - Minor stroke; 5-15 - Moderate stroke; 16-20 - Moderate to severe stroke; 21-42 - Severe stroke
Measured: every day for 7 days after stroke onset
National Institute of Health Stroke Scale
National Institute of Health Stroke Scale; score range: 1-42; 1-4 - Minor stroke; 5-15 - Moderate stroke; 16-20 - Moderate to severe stroke; 21-42 - Severe stroke
Measured: at day 30 after stroke onset
Detection of hemorrhagic transformation [range o:1]
hemorrhagic transformation on head computerized tomography
Measured: within 1 to 3 days after stroke onset, after worsening of clinical status by more than 4 points in NIHSS
Concentration of plasma occludin [ng/mL]
Occludin is an enzyme (EC 1.6) that oxidizes NADH (Nicotinamide adenine dinucleotide)
Measured: at the admission, within 1 to 3 days after stroke onset
Concentration of plasma occludin [ng/mL]
Occludin is an enzyme (EC 1.6) that oxidizes NADH (Nicotinamide adenine dinucleotide)
Measured: at 7th day after stroke onset
Concentration of plasma claudin 5 [ng/mL]
Claudins are small (20-24/27 kilodalton (kDa)) transmembrane proteins.
Measured: at the admission, within 1 to 3 days after stroke onset
Concentration of plasma claudin 5 [ng/mL]
Claudins are small (20-24/27 kilodalton (kDa)) transmembrane proteins.
Measured: at 7th day after stroke onset
Concentration of plasma ZO1 [ng/mL]
Zonula occludens-1 ZO-1, also known as Tight junction protein-1
Measured: at the admission, within 1 to 3 days after stroke onset
Concentration of plasma ZO1 [ng/mL]
Zonula occludens-1 ZO-1, also known as Tight junction protein-1
Measured: at 7th day after stroke onset
Secondary outcomes (8)
Modified Rankin scale [range 0:6]
Modified Rankin scale; 0-2 - good functional outcome; 3-6 - poor functional outcome
Measured: at the admission, within 1 to 3 days after stroke onset
Modified Rankin scale [range 0:6]
Modified Rankin scale; 0-2 - good functional outcome; 3-6 - poor functional outcome
Measured: at 7th day after stroke onset
Modified Rankin scale [range 0:6]
Modified Rankin scale; 0-2 - good functional outcome; 3-6 - poor functional outcome
Measured: at the 30th +/- 5 day after stroke onset
Modified Rankin scale [range 0:6]
Modified Rankin scale; 0-2 - good functional outcome; 3-6 - poor functional outcome
Measured: at 90th +/- 5 day after stroke onset
Barthel Index for Activities of Daily Living (ADL) [range 0:100]
measures the degree of assistance required by an individual; 0-20 - total dependency, 21-60 - severe dependency, 61-90 - moderate dependency, 91-100 - slight dependency
Measured: 30th +/- 5 day after stroke onset
Barthel Index for Activities of Daily Living (ADL) [range 0:100]
measures the degree of assistance required by an individual; 0-20 - total dependency, 21-60 - severe dependency, 61-90 - moderate dependency, 91-100 - slight dependency
Measured: at the 90th +/- 5 day after stroke onset
Death [range 0:1]
survival measure
Measured: within 90 days after stroke onset
Montreal Cognitive Assessment Test [range 0:30]
the assessment of cognitive functions; 26-30 - normal cognition, 18-25 - mild cognitive impairment, 10-17 - moderate cognitive impairment, <10 - severe cognitive impairment
Measured: at the 90th +/-5 day after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start10 Jan 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective longitudinal study will be performed in ischemic stroke patients who: 1. are included for reperfusion therapy (intravenous thrombolysis and/or mechanical thrombectomy - control (group A), 2. are included for reperfusion therapy (intravenous thrombolysis and/or mechanical thrombectomy plus Cerebrolysin (group B) 3. are not referred to reperfusion therapy nor Cerebrolysin (group C).
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Slawomir Michalak, Prof., Principal investigator, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078215
- Sponsor's protocol ID
- 392/2023
- Acronym
- CERBERUS
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kazmierski R, Michalak S, Wencel-Warot A, Nowinski WL. Serum tight-junction proteins predict hemorrhagic transformation in ischemic stroke patients. Neurology. 2012 Oct 16;79(16):1677-85. doi: 10.1212/WNL.0b013e31826e9a83. Epub 2012 Sep 19.
PubMed 22993287Poljakovic Z, Supe S, Ljevak J, Starcevic K, Peric I, Blazevic N, Krbot-Skoric M, Jovanovic I, Ozretic D. Efficacy and safety of Cerebrolysin after futile recanalisation therapy in patients with severe stroke. Clin Neurol Neurosurg. 2021 Aug;207:106767. doi: 10.1016/j.clineuro.2021.106767. Epub 2021 Jun 18.
PubMed 34214867Teng H, Li C, Zhang Y, Lu M, Chopp M, Zhang ZG, Melcher-Mourgas M, Fleckenstein B. Therapeutic effect of Cerebrolysin on reducing impaired cerebral endothelial cell permeability. Neuroreport. 2021 Mar 24;32(5):359-366. doi: 10.1097/WNR.0000000000001598.
PubMed 33661804Kassner A, Roberts T, Taylor K, Silver F, Mikulis D. Prediction of hemorrhage in acute ischemic stroke using permeability MR imaging. AJNR Am J Neuroradiol. 2005 Oct;26(9):2213-7.
PubMed 16219824Zhang Y, Chopp M, Zhang ZG, Zhang Y, Zhang L, Lu M, Zhang T, Winter S, Doppler E, Brandstaetter H, Mahmood A, Xiong Y. Cerebrolysin Reduces Astrogliosis and Axonal Injury and Enhances Neurogenesis in Rats After Closed Head Injury. Neurorehabil Neural Repair. 2019 Jan;33(1):15-26. doi: 10.1177/1545968318809916. Epub 2018 Nov 30.
PubMed 30499355Lang W, Stadler CH, Poljakovic Z, Fleet D; Lyse Study Group. A prospective, randomized, placebo-controlled, double-blind trial about safety and efficacy of combined treatment with alteplase (rt-PA) and Cerebrolysin in acute ischaemic hemispheric stroke. Int J Stroke. 2013 Feb;8(2):95-104. doi: 10.1111/j.1747-4949.2012.00901.x. Epub 2012 Sep 26.
PubMed 23009193
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CERebrolysine Effect on Blood-brain Barrier / Endothelium Integrity During Reperfusion Therapy of acUte Ischemic Stroke (CERBERUS Study)
- ClinicalTrials.gov ID
- NCT06078215
- Acronym / sponsor ID
- CERBERUS / 392/2023
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, blood-brain barrier, cerebrolysin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 11 Oct 2023 (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.
The study investigates whether Cerebrolysin stabilizes blood-brain barrier integrity in a manner that can be monitored using serum levels of the principal tight junction proteins, e.g., occludin (OCL), claudin-5 (CLN), and zonula occludens-1 (ZO-1), or other molecules known to be involved in BBB degradation, e.g., S100B and whether it protects against hemorrhagic transformation in ischemic stroke patients after reperfusion therapy (i.e. thrombolysis and/or mechanical thrombectomy).
Detailed description
Hemorrhagic transformation (HT) of ischemic stroke can be identified in 3-40% of patients. The incidence varies depending on the definition used and the studied population. The severity of HT can be described using clinical and radiological tools and classified as asymptomatic/symptomatic, according to European Cooperative Acute Stroke Study classification and Heidelberg Bleeding Classification. Breakdown of the blood-brain barrier (BBB) is associated with an increased risk of developing a hemorrhagic transformation (HT) of ischemic stroke. In patients who received reperfusion therapy (thrombolysis, mechanical thrombectomy), secondary HT had a negative influence on the clinical course and outcome.
Tight junction (TJ) proteins are important cell adhesion components that stabilize endothelium cells lining and are responsible for maintaining the BBB integrity.
Biomarkers of BBB damage that can be evaluated during the early phases of stroke might be useful for predicting the risk of HT. Such biomarkers could also facilitate the decision of whether to begin thrombolytic therapy in acute ischemic stroke patients. Experimental data support the evidence for protective effect of Cerebrolysin on BBB integrity. Moreover, it diminished and reversed negative effect of recombinant tissue plasminogen activator (rtPA) used as thrombolytic agent on endothelial cells integrity. Cerebrolysin stabilized tight junction proteins expression: occludin, claudin-5 and zona occludens 1 (ZO1). In our previous study we have found that circulating TJs predict HT in ischemic stroke patients. Clinically evident HTs were associated with increased concentrations of occludin and S100B, an increase in the claudin-5/ZO-1 ratio, and a decreased level of vascular endothelial growth factor (VEGF). Claudin-5 levels also correlated with HT occurrence when estimated within 3 hours of stroke onset. The protective effects of Cerebrolysin were already clinically evidenced, however there are no available studies using biomarkers of BBB.
Aim of the study
We aim to investigate whether Cerebrolysin stabilizes BBB integrity in a manner that can be monitored using serum levels of the principal TJ proteins, e.g., occludin (OCL), claudin-5 (CLN), and zonula occludens-1 (ZO-1), or other molecules known to be involved in BBB degradation, e.g., S100B and whether it protects against HT in ischemic stroke patients after reperfusion therapy.
Study design
A prospective longitudinal study will be performed in ischemic stroke patients who:
- are included for reperfusion therapy (intravenous thrombolysis and/or mechanical thrombectomy - control (group A),
- are included for reperfusion therapy (intravenous thrombolysis and/or mechanical thrombectomy plus Cerebrolysin (group B)
- are not referred to reperfusion therapy nor Cerebrolysin (group C).
All patients with NIHSS score > 8 will receive 30 ml Cerebrolysin in 500 ml of buffered crystalloid solution intravenously initiated within 12 hours from symptoms onset.
Whole blood samples will be withdrawn at the admission, then within 1 to 3 days after stroke onset and at 7th day after stroke onset or when the endpoint will be reached by the patient. Occludin, claudin 5 and ZO-1 concentrations will be analyzed by means of home-made enzyme-linked immunosorbent assay.
Endpoint will include clinical worsening (increase in the NIHSS by > 4 points), radiologically evident hemorrhage or radiologically evident brain edema at control CT performed within 1 to 3 days after stroke onset.
Standard head CT will be performed in all patients at the admission, within 1 to 3 days after stroke onset, after worsening of clinical status and additionally when the differentiation between hemorrhage and contrast staining will be required in thrombectomy patients. Hemorrhagic transformation of ischemic stroke will be classified according to Table 1.
Clinimetric evaluation of all patients will include NIHSS every day for 7 days and at day 30. Modified Rankin scale (mRS) will be evaluated at visit 1,2,3,4 and 5; Barthel index at visit 4 and 5 and Montreal Cognitive Assessment Test at visit 5.
All patents will undergo current American Heart Association Guidelines for the Early Management of Patients with Acute Ischemic Stroke.
Expected results It is expected that Cerebrolysin can stabilize blood-brain barrier in ischemic stroke patients treated with reperfusion therapies via remodelling of tight junction proteins between endothelial cells. Such an effect measured by the levels of circulating tight junction proteins can translate into prevention of hemorrhagic transformation. To summarize, Cerebrolysine can guard blood-brain barrier integrity in ischemic stroke (Cerberus effect).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A prospective longitudinal study will be performed in ischemic stroke patients who: 1. are included for reperfusion therapy (intravenous thrombolysis and/or mechanical thrombectomy - control (group A), 2. are included for reperfusion therapy (intravenous thrombolysis and/or mechanical thrombectomy plus Cerebrolysin (group B) 3. are not referred to reperfusion therapy nor Cerebrolysin (group C).
| Arm | Type | Receives |
|---|---|---|
| Thrombolysis and/or mechanical thrombectomy | No intervention | –patients included for reperfusion therapy (intravenous thrombolysis and/or mechanical thrombectomy - comparator |
| Cerebrolysin | Experimental | Combination Product: Cerebrolysinpatients included for reperfusion therapy (intravenous thrombolysis and/or mechanical thrombectomy and treated with Cerebrolysin |
| No reperfusion therapy / no cerebrolysin | No intervention | –patients not referred to reperfusion therapy nor Cerebrolysin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acute ischemic stroke patients
- informed consent
Key exclusion criteria (10 listed)
- no informed consent
- primary or metastatic brain tumor
- brain abscess
- encephalitis
- localized inflammation
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: FPF (Fine Particle Fraction)-1070Intravenous infusion of 30 ml Cerebrolysine in 500 ml of buffered crystalloid solution intravenously initiated within 12 hours from symptoms onset | Combination product | Cerebrolysin |
Primary outcome
National Institute of Health Stroke Scale
Time frame: every day for 7 days after stroke onset
National Institute of Health Stroke Scale; score range: 1-42; 1-4 - Minor stroke; 5-15 - Moderate stroke; 16-20 - Moderate to severe stroke; 21-42 - Severe stroke
National Institute of Health Stroke Scale
Time frame: at day 30 after stroke onset
National Institute of Health Stroke Scale; score range: 1-42; 1-4 - Minor stroke; 5-15 - Moderate stroke; 16-20 - Moderate to severe stroke; 21-42 - Severe stroke
Detection of hemorrhagic transformation [range o:1]
Time frame: within 1 to 3 days after stroke onset, after worsening of clinical status by more than 4 points in NIHSS
hemorrhagic transformation on head computerized tomography
Concentration of plasma occludin [ng/mL]
Time frame: at the admission, within 1 to 3 days after stroke onset
Occludin is an enzyme (EC 1.6) that oxidizes NADH (Nicotinamide adenine dinucleotide)
Concentration of plasma occludin [ng/mL]
Time frame: at 7th day after stroke onset
Occludin is an enzyme (EC 1.6) that oxidizes NADH (Nicotinamide adenine dinucleotide)
Concentration of plasma claudin 5 [ng/mL]
Time frame: at the admission, within 1 to 3 days after stroke onset
Claudins are small (20-24/27 kilodalton (kDa)) transmembrane proteins.
Concentration of plasma claudin 5 [ng/mL]
Time frame: at 7th day after stroke onset
Claudins are small (20-24/27 kilodalton (kDa)) transmembrane proteins.
Concentration of plasma ZO1 [ng/mL]
Time frame: at the admission, within 1 to 3 days after stroke onset
Zonula occludens-1 ZO-1, also known as Tight junction protein-1
Concentration of plasma ZO1 [ng/mL]
Time frame: at 7th day after stroke onset
Zonula occludens-1 ZO-1, also known as Tight junction protein-1
8 secondary outcomes
Modified Rankin scale [range 0:6]
Time frame: at the admission, within 1 to 3 days after stroke onset
Modified Rankin scale [range 0:6]
Time frame: at 7th day after stroke onset
Modified Rankin scale [range 0:6]
Time frame: at the 30th +/- 5 day after stroke onset
Modified Rankin scale [range 0:6]
Time frame: at 90th +/- 5 day after stroke onset
Barthel Index for Activities of Daily Living (ADL) [range 0:100]
Time frame: 30th +/- 5 day after stroke onset
Barthel Index for Activities of Daily Living (ADL) [range 0:100]
Time frame: at the 90th +/- 5 day after stroke onset
Death [range 0:1]
Time frame: within 90 days after stroke onset
Montreal Cognitive Assessment Test [range 0:30]
Time frame: at the 90th +/-5 day after stroke onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Background: PubMed 22993287Kazmierski R, Michalak S, Wencel-Warot A, Nowinski WL. Serum tight-junction proteins predict hemorrhagic transformation in ischemic stroke patients. Neurology. 2012 Oct 16;79(16):1677-85. doi: 10.1212/WNL.0b013e31826e9a83. Epub 2012 Sep 19.
- Background: PubMed 34214867Poljakovic Z, Supe S, Ljevak J, Starcevic K, Peric I, Blazevic N, Krbot-Skoric M, Jovanovic I, Ozretic D. Efficacy and safety of Cerebrolysin after futile recanalisation therapy in patients with severe stroke. Clin Neurol Neurosurg. 2021 Aug;207:106767. doi: 10.1016/j.clineuro.2021.106767. Epub 2021 Jun 18.
- Background: PubMed 33661804Teng H, Li C, Zhang Y, Lu M, Chopp M, Zhang ZG, Melcher-Mourgas M, Fleckenstein B. Therapeutic effect of Cerebrolysin on reducing impaired cerebral endothelial cell permeability. Neuroreport. 2021 Mar 24;32(5):359-366. doi: 10.1097/WNR.0000000000001598.
- Background: PubMed 16219824Kassner A, Roberts T, Taylor K, Silver F, Mikulis D. Prediction of hemorrhage in acute ischemic stroke using permeability MR imaging. AJNR Am J Neuroradiol. 2005 Oct;26(9):2213-7.
- Background: PubMed 30499355Zhang Y, Chopp M, Zhang ZG, Zhang Y, Zhang L, Lu M, Zhang T, Winter S, Doppler E, Brandstaetter H, Mahmood A, Xiong Y. Cerebrolysin Reduces Astrogliosis and Axonal Injury and Enhances Neurogenesis in Rats After Closed Head Injury. Neurorehabil Neural Repair. 2019 Jan;33(1):15-26. doi: 10.1177/1545968318809916. Epub 2018 Nov 30.
- Background: PubMed 23009193Lang W, Stadler CH, Poljakovic Z, Fleet D; Lyse Study Group. A prospective, randomized, placebo-controlled, double-blind trial about safety and efficacy of combined treatment with alteplase (rt-PA) and Cerebrolysin in acute ischaemic hemispheric stroke. Int J Stroke. 2013 Feb;8(2):95-104. doi: 10.1111/j.1747-4949.2012.00901.x. Epub 2012 Sep 26.
- 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.
Slawomir Michalak, Prof. principal investigator
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cerebrolysin in people with Acute Ischemic Stroke, run by Poznan University of Medical Sciences 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 2 inclusion and 10 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 13 Oct 2023. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Slawomir Michalak, Prof. (+48 61 8691 535, swami@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institute of Health Stroke Scale (time frame: every day for 7 days after stroke onset). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06078215, which also lists 6 linked publications.
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 13 Oct 2023.