Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489925
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-28
Brief Title:
Cerebrolysin as an Add-On Therapy to Standard Treatment of Basilar Artery Occlusion
Sponsor:
University Hospital Sestre Milosrdnice
Organization:
University Hospital Sestre Milosrdnice
Study Overview
Official Title:
Cerebrolysin as an Add-On Therapy to Standard Treatment of Posterior Circulation Stroke Secondary to Basilar Artery Occlusion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The standard therapy for acute ischemic posterior circulation stroke PCS often leads to poor functional outcomes and high mortality rates despite all advances in reperfusion therapy Recent trials have shown that adding Cerebrolysin a cerebral neuroprotective agent to standard therapy for patients with acute ischemic anterior circulation stroke is safe and leads to improved functional outcomes The purpose of this study is to assess the effectiveness and safety of Cerebrolysin with standard treatment for patients with PCS secondary to basilar artery occlusion BAO
The plan is to conduct a prospective single-center single-arm open-label study with 20 acute basilar artery occlusion patients and premorbid modified Rankin Score mRS 3 treated with standard treatment mechanical thrombectomy intravenous alteplase or conservative treatment and Cerebrolysin as add-on therapy compared with historical controls Besides standard acute stroke assessment standard treatment and rehabilitation the participants who meet the eligibility criteria will receive Cerebrolysin in a single-day dosage of 30 ml intravenously for 14 consecutive days The participants will be closely monitored and neuroimaging findings and clinical outcomes will be obtained during the drug administration period on discharge one month and 3 months after the treatment onset
The primary endpoints are mRS 0-3 on day 90 and mortality rate 90 days after the stroke onset The secondary endpoints are defined as a change in any type of intracerebral bleeding and a change of min 2 points on the National Institutes of Health Stroke Scale 24 hours 14 days 30 days and 90 days post-stroke
The investigators hypothesize that adding Cerebrolysin to standard stroke treatment will improve clinical outcomes and reduce morbidity and mortality in patients with acute basilar occlusion compared to standard treatment alone
The plan is to conduct a prospective single-center single-arm open-label study with 20 acute basilar artery occlusion patients and premorbid modified Rankin Score mRS 3 treated with standard treatment mechanical thrombectomy intravenous alteplase or conservative treatment and Cerebrolysin as add-on therapy compared with historical controls Besides standard acute stroke assessment standard treatment and rehabilitation the participants who meet the eligibility criteria will receive Cerebrolysin in a single-day dosage of 30 ml intravenously for 14 consecutive days The participants will be closely monitored and neuroimaging findings and clinical outcomes will be obtained during the drug administration period on discharge one month and 3 months after the treatment onset
The primary endpoints are mRS 0-3 on day 90 and mortality rate 90 days after the stroke onset The secondary endpoints are defined as a change in any type of intracerebral bleeding and a change of min 2 points on the National Institutes of Health Stroke Scale 24 hours 14 days 30 days and 90 days post-stroke
The investigators hypothesize that adding Cerebrolysin to standard stroke treatment will improve clinical outcomes and reduce morbidity and mortality in patients with acute basilar occlusion compared to standard treatment alone
Detailed Description:
The investigators plan to conduct a prospective single-center single-arm open-label study with 20 acute basilar artery occlusion patients with premorbid modified Rankin Score mRS 3 treated with standard treatment mechanical thrombectomy intravenous thrombolysis with alteplase or conservative treatment and Cerebrolysin as add-on therapy compared with historical controls
All participants will receive the same standard of care and will be treated according to the latest European Stroke Organisation and American Stroke Organisation guidelines on acute stroke
Besides standard acute stroke assessment treatment and acute rehabilitation the participants who meet the eligibility criteria are informed about the study and its potential risks and have written informed consent will receive Cerebrolysin in a single-day dosage of 30 ml intravenously for 14 consecutive days The Cerebrolysin administration will start no earlier than one hour after the standard treatment and no later than 24 hours after the stroke symptom onset All possible side-effects will be closely monitored and in case of any adverse effect the drug administration will be stopped and the participant will be excluded from the further trial
The participants will be closely monitored and the data on possible drug side effects adverse effects clinical findings laboratory findings and neuroimaging findings will be stored in the centralized hospital database The clinical assessment and imaging analysis will be performed by an unbiased third-party neurologistneuroradiologist
The clinical findings and outcomes will be quantified by the National Institutes of Health Stroke Scale NIHSS 24 hours 14 days 30 days and 90 days post-stroke and by the Modified Rankin Scale on discharge and 90 days post-stroke The participants will undergo CT MRI neuroimaging for intracranial bleeding detection during admission 24 hours after the stroke and on discharge from the hospital An additional imaging will be performed if indicated
The interventional group and historical controls will be matched 11 based on the site of the basilar artery occlusion proximal middle distal part and further matched by the National Institutes of Health Stroke Scale score on admission to hospital 0-4 4-1516-20 21-42 premorbid Modified Rankin Scale score MSCT brain findings on admission to hospital ischemia no ischemia time from symptom onset to treatment 0-3h 3-6h later than 6 h age - 5 years type of treatment conservative treatment intravenous thrombolysis with alteplase mechanical thrombectomy intravenous thrombolysis with alteplase mechanical thrombectomy type of mechanical thrombectomy intracranial basilar artery stenting performednot performed and comorbid arterial hypertension yes or no
The data for historical controls will be obtained retrospectively from the Central Hospital Database which contains demographic clinical laboratory and neuroimaging records of all patients with posterior circulation stroke secondary to basilar artery occlusion treated in the same Center from January 2015 to May 2024 The data will be analyzed and the results will be compared between the investigational group and historical controls
All participants will receive the same standard of care and will be treated according to the latest European Stroke Organisation and American Stroke Organisation guidelines on acute stroke
Besides standard acute stroke assessment treatment and acute rehabilitation the participants who meet the eligibility criteria are informed about the study and its potential risks and have written informed consent will receive Cerebrolysin in a single-day dosage of 30 ml intravenously for 14 consecutive days The Cerebrolysin administration will start no earlier than one hour after the standard treatment and no later than 24 hours after the stroke symptom onset All possible side-effects will be closely monitored and in case of any adverse effect the drug administration will be stopped and the participant will be excluded from the further trial
The participants will be closely monitored and the data on possible drug side effects adverse effects clinical findings laboratory findings and neuroimaging findings will be stored in the centralized hospital database The clinical assessment and imaging analysis will be performed by an unbiased third-party neurologistneuroradiologist
The clinical findings and outcomes will be quantified by the National Institutes of Health Stroke Scale NIHSS 24 hours 14 days 30 days and 90 days post-stroke and by the Modified Rankin Scale on discharge and 90 days post-stroke The participants will undergo CT MRI neuroimaging for intracranial bleeding detection during admission 24 hours after the stroke and on discharge from the hospital An additional imaging will be performed if indicated
The interventional group and historical controls will be matched 11 based on the site of the basilar artery occlusion proximal middle distal part and further matched by the National Institutes of Health Stroke Scale score on admission to hospital 0-4 4-1516-20 21-42 premorbid Modified Rankin Scale score MSCT brain findings on admission to hospital ischemia no ischemia time from symptom onset to treatment 0-3h 3-6h later than 6 h age - 5 years type of treatment conservative treatment intravenous thrombolysis with alteplase mechanical thrombectomy intravenous thrombolysis with alteplase mechanical thrombectomy type of mechanical thrombectomy intracranial basilar artery stenting performednot performed and comorbid arterial hypertension yes or no
The data for historical controls will be obtained retrospectively from the Central Hospital Database which contains demographic clinical laboratory and neuroimaging records of all patients with posterior circulation stroke secondary to basilar artery occlusion treated in the same Center from January 2015 to May 2024 The data will be analyzed and the results will be compared between the investigational group and historical controls
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None