Clinical Trial

Single Bolus Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke Within 4.5-24 Hours of Symptom Onset

Study acronym: FRIDA-CT
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
Multicenter, double-blind, randomized, placebo-controlled phase III clinical trial. At the clinical sites, patients with acute ischemic stroke within 4.5-24 hours of symptom onset will be randomized to receive a single bolus injection of the recombinant non-immunogenic staphylokinase (Fortelyzin®, LLC "SuperGene", Russia) or placebo.
Protocol Amendment History 3 changes
critical Primary endpoint(s) modified 2026-07-24
notable Trial sites expanded: 15 -> 22 locations 2026-07-24
critical Recruitment opened 2026-06-13
Trial Details
NCT Number NCT07324837
Lead Sponsor Supergene, LLC
Conditions Ischemic Stroke, Acute
Enrollment 990 participants
Start Date 2026-06-09
Primary Completion 2028-11-01 (estimated)
Study Completion 2029-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-23