Cerebrolysin as an Add-On Therapy to Standard Treatment of Basilar Artery Occlusion
NCT Number: NCT06489925
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Basilar Artery Occlusion|Posterior Circulation Brain Infarction
Interventions: DRUG: Cerebrolysin
Sponsor: University Hospital "Sestre Milosrdnice"
Collaborators: Ever Neuro Pharma GmbH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-05

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.

Primary Outcome Measures: 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., 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., 90 days (3 months) after the stroke
Secondary Outcome Measures: 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"., 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., 24 hours, 14 days, and 90 days after the stroke