Sergiyev Posad

Researchers are investigating the use of a recombinant non-immunogenic staphylokinase Fortelyzin in patients who have experienced an acute ischemic stroke between 4.5 and 24 hours after symptom onset. This phase III, multicenter, double-blind, randomized, placebo-controlled trial aims to evaluate the efficacy and safety of this drug in restoring blood flow in patients with large vessel occlusion stroke who arrive outside the standard 4.5-hour treatment window. The study focuses on patients with salvageable brain tissue identified by advanced imaging techniques. Participants will be randomly assigned to receive either a single intravenous bolus injection of 10 mg non-immunogenic staphylokinase or a placebo administered rapidly within 5 to 10 seconds regardless of body weight. The trial excludes patients planned for direct thrombectomy. Following treatment, patients will be monitored for up to 90 days to assess outcomes. The trial evaluates functional recovery and reperfusion improvements compared to placebo. Throughout the study, participants will undergo imaging assessments such as CT or MRI perfusion scans to confirm eligibility and monitor brain tissue status. Researchers will evaluate functional outcomes using established stroke scales over 90 days, including the modified Rankin Scale and NIH Stroke Scale. Safety, mortality, and reperfusion rates will also be tracked. Participants will have follow-up visits and assessments designed to measure recovery and treatment impact over the trial period.

This research aims to evaluate the effectiveness and safety of intra-arterial intrathrombus administration of recombinant non-immunogenic staphylokinase Fortelyzin4 compared to surgery in patients experiencing acute limb ischemia ALI. ALI is a serious condition with high mortality, and this study focuses on a thrombolytic treatment that targets clot breakdown directly within affected arteries. The trial builds on previous studies showing promising results with this staphylokinase in heart attacks and strokes, assessing its role specifically in ALI. Participants will be randomly assigned to receive either Fortelyzin4 delivered directly into the blood clot via a catheter or surgical treatment including endovascular intervention, open surgery, or bypass surgery based on current national guidelines. The Fortelyzin4 treatment involves an initial bolus injection followed by a continuous infusion over ten hours through a perforated multihole catheter. Surgery will be conducted according to standard practice. This is an open-label, multicenter Phase 3 trial. During the study, participants will be monitored for 30 days after randomization to assess outcomes, focusing primarily on the number of patients who avoid amputation. Assessments will include safety monitoring for bleeding and other adverse events. Informed consent and contraception adherence are required, and ongoing patient evaluations will help researchers understand the comparative benefits and risks of these treatment approaches for ALI.