An Early Phase 1 interventional study of Cerebrolysin in Basilar Artery Occlusion and Posterior Circulation Brain Infarction, sponsored by University Hospital Sestre Milosrdnice. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by University Hospital Sestre Milosrdnice · Early Phase 1, Interventional, and Treatment
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 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 neurologist/neuroradiologist.
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 1:1 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, 4-15,16-20, 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 performed/not 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.
93 studies on the registry are indexed under Brain Infarction; 19 are open to participants now.
This study's planned enrollment of 20 is below the median of 134 across 67 interventional studies indexed under Brain Infarction.
Browse Brain Infarction studies →University Hospital Sestre Milosrdnice is the lead sponsor of 27 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with acute basilar artery occlusion who meet the eligibility criteria will receive Cerebrolysin in a single-day dosage of 30 ml, diluted with 250 ml of 0.9% saline intravenously in the first 24 hours after the stroke. Cerebrolysin will be further administered in the same dosage once daily in the morning for 14 consecutive days.
Drug: Cerebrolysin
The Cerebrolysin will be administered at least one hour after the standard treatment and no later than 24 hours after the stroke symptom onset.
Also known as: Cerebrolysin®
Percentage of participants in the Cerebrolysin group with the Modified Rankin Scale (mRS) score 0-3 at 90 days post-stroke compared to historical controls
The functional outcomes will be assessed using the Modified Rankin Scale (mRS), with scores ranging from 0 (best functional outcome) to 6 (worst functional outcome). In the context of posterior circulation stroke, a favorable functional outcome is defined as an mRS score of ≤3 on day 90 post-stroke.
Time frame: 90 days (3 months) after the stroke
Mortality rate in the Cerebrolysin group compared to historical controls
The mortality rate will be assessed using the Modified Rankin Scale, which ranges from 0 to 6, where a score of 6 corresponds to the "death" outcome.
Time frame: 90 days (3 months) after the stroke
Change in any and symptomatic intracerebral bleeding in the Cerebrolysin group compared to historical controls
The follow-up computed tomography scans will be performed 24 hours and 14 days after the stroke. Additional scans will be obtained when indicated (before introducing anticoagulant therapy, in case of clinical deterioration with an increase of ≥4 points on the NIHSS from baseline or the lowest value within 7 days, in case of death, or for other reasons). Types of intracerebral bleeding and symptomatic intracerebral bleeding will be classified according to the ECASS III trial classification. Other types of bleeding which cannot be classified by ECASS III classification will be listed as "other".
Time frame: 24 hours and 14 days after the stroke
Change in the National Institutes of Health Stroke Scale (NIHSS) compared to historical controls
The clinical outcomes will be evaluated using the National Institutes of Health Stroke Scale (NIHSS), which ranges from 0 to 42. Lower scores indicate a better clinical outcome, while higher scores indicate a worse outcome. A change of at least 2 points on the National Institutes of Health Stroke Scale (NIHSS) is considered significant.
Time frame: 24 hours, 14 days, and 90 days after the stroke
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This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cerebrolysin
University Hospital Sestre Milosrdnice