Can adding cerebrolysin early to clot-dissolving stroke treatment reduce the risk of brain bleeding?

Current interventions as of 25/11/2024: Participants will be randomized in a 1:2 ratio into either the case or control group using a computer-generated randomization process. • Control group: Particip

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Current participant inclusion criteria as of 25/11/2024: 1. Patients with a confirmed diagnosis of acute ischemic stroke (AIS) 2. Male or female participants 3. Age =18 years 4. Admission to one of the study sites within 4.5 hours of AIS onset 5. Indications for IVT Previous participant inclusion criteria: 1. Patients with confirmed diagnosis of acute ischemic stroke (AIS) 2. Male or female gender 3. Age =18 years 4. Admission to one of the sites within 4.5 h after the AIS onset 5. Indications for intravenous thrombolytic therapy

Exclusion criteria

Exclusion criteria: Current participant exclusion criteria as of 25/11/2024: 1. Contraindications for IVT 2. Contraindications for Cerebrolysin 3. Evidence of hemorrhagic transformation or intracranial hemorrhage on the screening CT scan 4. Any other concurrent life-threatening medical conditions Previous participant exclusion criteria: 1. Contraindications for intravenous thrombolytic therapy 2. Contraindications for Cerebrolysin 3. Signs of hemorrhagic transformation or intracranial hemorrhage on the screening CT scan 4. Any other concurrent life-threatening medical condition

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 25/11/2024: The rate of hemorrhagic transformation (both any and symptomatic) will be assessed using follow-up non-contrast brain computed tomography (CT) scans. CT scans will be performed 24 hours after IVT (visit 1), on day 7 (visit 2), day 14 (visit 3), and additionally if requested by the treating neurologist. Symptomatic intracranial hemorrhage will be defined according to the ECASS III criteria as any visible extravascular blood in the brain or cranium associated with clinical deterioration (an increase of =4 points on the NIH Stroke Scale [NIHSS]) or resulting in death. Previous primary outcome measure: Rate of hemorrhagic transformation (any and symptomatic) on any of follow-up non-contrast brain computed tomography (CT) scan. CT is performed 24 h after the IV TLT (visit 1), on day 7 (visit 2), 14 (visit 3) and if required by a treating neurologist. Symptomatic intracranial hemorrhage was defined according the ECASS III study as any apparently extravascular blood in the brain or within the cranium that is associated with clinical deterioration (an increase of =4 points on the NIHSS), or led to death.	—

Measure

Time frame

Current primary outcome measure as of 25/11/2024: The rate of hemorrhagic transformation (both any and symptomatic) will be assessed using follow-up non-contrast brain computed tomography (CT) scans. CT scans will be performed 24 hours after IVT (visit 1), on day 7 (visit 2), day 14 (visit 3), and additionally if requested by the treating neurologist. Symptomatic intracranial hemorrhage will be defined according to the ECASS III criteria as any visible extravascular blood in the brain or cranium associated with clinical deterioration (an increase of =4 points on the NIH Stroke Scale [NIHSS]) or resulting in death. Previous primary outcome measure: Rate of hemorrhagic transformation (any and symptomatic) on any of follow-up non-contrast brain computed tomography (CT) scan. CT is performed 24 h after the IV TLT (visit 1), on day 7 (visit 2), 14 (visit 3) and if required by a treating neurologist. Symptomatic intracranial hemorrhage was defined according the ECASS III study as any apparently extravascular blood in the brain or within the cranium that is associated with clinical deterioration (an increase of =4 points on the NIHSS), or led to death.

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Secondary

Measure	Time frame
Current secondary outcome measure as of 25/11/2024: 1. Functional outcome measured using the National Institutes of Health Stroke Scale (NIHSS) at 24 hours (visit 1), and on days 3 (visit 2) and 14 (visit 3) 2. Functional outcome measured using the modified Rankin Scale on day 90 (visit 4) 3. Permeability-surface area product measured using diffusion-tensor imaging (including fractional anisotropy, axial, radial, and mean diffusivity) and CT-perfusion imaging (measuring the ) at 24 hours after intravenous thrombolysis (DTI only) and on day 14 (DTI and CTP) 4. Adverse events measured using interviews during follow-up at 24 hours, days 3, and 14, along with the evaluation of vital signs (blood pressure, heart rate), standard biochemical panel, and complete blood count at admission and on day 14 Previous secondary outcome measure: 1. Functional outcome measured using National Institutes of Health Stroke Scale (NIHSS) score at (visits 1, 2, 3 and on day 90 (visit 4) 2. Functional outcome measured using modified Rankin scale score at day 14 and 90 3. Blood-brain barrier permeability measures: fractional anisotropy, axial and radial diffusivity, permeability-surface area product measured using axial diffusion-tensor imaging at 24 h after the IV TLT, on day 14 and brain CT perfusion on day 14 and 90 4. Adverse events are assessed by interview during the follow-up 5. Vital signs (blood pressure, heart rate), standard biochemical panel and complete blood count (blood test) are evaluated at admission and on day 14 6. C-reactive protein is measured by blood test at visit 1	—

Measure

Time frame

Current secondary outcome measure as of 25/11/2024: 1. Functional outcome measured using the National Institutes of Health Stroke Scale (NIHSS) at 24 hours (visit 1), and on days 3 (visit 2) and 14 (visit 3) 2. Functional outcome measured using the modified Rankin Scale on day 90 (visit 4) 3. Permeability-surface area product measured using diffusion-tensor imaging (including fractional anisotropy, axial, radial, and mean diffusivity) and CT-perfusion imaging (measuring the ) at 24 hours after intravenous thrombolysis (DTI only) and on day 14 (DTI and CTP) 4. Adverse events measured using interviews during follow-up at 24 hours, days 3, and 14, along with the evaluation of vital signs (blood pressure, heart rate), standard biochemical panel, and complete blood count at admission and on day 14 Previous secondary outcome measure: 1. Functional outcome measured using National Institutes of Health Stroke Scale (NIHSS) score at (visits 1, 2, 3 and on day 90 (visit 4) 2. Functional outcome measured using modified Rankin scale score at day 14 and 90 3. Blood-brain barrier permeability measures: fractional anisotropy, axial and radial diffusivity, permeability-surface area product measured using axial diffusion-tensor imaging at 24 h after the IV TLT, on day 14 and brain CT perfusion on day 14 and 90 4. Adverse events are assessed by interview during the follow-up 5. Vital signs (blood pressure, heart rate), standard biochemical panel and complete blood count (blood test) are evaluated at admission and on day 14 6. C-reactive protein is measured by blood test at visit 1

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Countries

Russian Federation

Contacts

Public ContactMikhail Kalinin

ninilak@gmail.com+79172959770

Outcome results

None listed