Cerebrolysin as an Add-On Therapy to Standard Treatment of Basilar Artery Occlusion

Status

Status unknown

Phase

Early phase 1

Enrollment

20 participants (estimated)

Sponsor

University Hospital Sestre Milosrdnice · Other

Design

Allocation not applicable · Open label (no masking)

Countries

Not stated

Start

Jul 2024 (estimated)

Primary completion

May 2025 (estimated)

Completion

May 2026 (estimated)

First posted

8 Jul 2024

Last update posted

9 Jul 2024

Conditions

Basilar Artery Occlusion · Posterior Circulation Brain Infarction

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.

• Experimental

  Cerebrolysin group

  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.

1. 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

   Time frame · 90 days (3 months) after the stroke

   Registry description

   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.

2. Mortality rate in the Cerebrolysin group compared to historical controls

   Time frame · 90 days (3 months) after the stroke

   Registry description

   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.