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Single Bolus Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke Within 4.5-24 Hours of Symptom Onset
Sponsor: Supergene, LLC
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.
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study of the Efficacy and Safety of the Recombinant Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke Within 4.5-24 Hours of Symptom Onset (FRIDA-CT)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
990
Start Date
2026-02-01
Completion Date
2029-01-01
Last Updated
2026-01-08
Healthy Volunteers
No
Conditions
Interventions
non-immunogenic staphylokinase
The non-immunogenic staphylokinase is given as a single intravenous bolus, 10 mg (within 5-10 seconds) immediately upon randomization regardless patient's bodyweight
Placebo
Placebo is given as a single intravenous bolus (within 5-10 seconds) immediately upon randomization
Locations (15)
Ryazan Regional Clinical Hospital
Ryazan, Ryazan Oblast, Russia
Altai Regional Clinical Hospital
Barnaul, Russia
Chelyabinsk Regional Clinical Hospital No. 3
Chelyabinsk, Russia
Irkutsk Regional Clinical Hospital
Irkutsk, Russia
Kaluga Regional Clinical Hospital
Kaluga, Russia
Interregional Clinical and Diagnostic Center
Kazan', Russia
S.V. Ochapovsky Research Institute - Regional Clinical Hospital No. 1
Krasnodar, Russia
N.I. Pirogov Russian National Research Medical University
Moscow, Russia
V.I. Voynov Orenburg Regional Clinical Hospital
Orenburg, Russia
Leningradskaya Regional Clinical Hospital
Saint Petersburg, Russia
Sergiev Posad District Hospital
Sergiyev Posad, Russia
Tver Regional Clinical Hospital
Tver', Russia
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, Russia
City Clinical Hospital of Emergency Medical Care No. 25
Volgograd, Russia
Sverdlovsk Regional Clinical Hospital No. 1
Yekaterinburg, Russia