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)
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Men and women aged 18 years and over;
• Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrolment, including wake-up stroke and unwitnessed stroke, onset time refers to last-seen normal time;
• Pre-stroke modified Rankin scale (mRS) score≤1;
• Internal carotid artery, middle cerebral artery M1 or M2 occlusion confirmed by CT/MRI, internal carotid artery, middle cerebral artery M1 or M2 being responsible for signs and symptoms of acute ischemic stroke;
• Neuroimaging: target mismatch profile on CT or MRI perfusion: ischemic core volume \<70 mL, mismatch ratio≥1.8 and mismatch volume≥15 mL;
• Alberta Stroke Program Early CT score (ASPECTS) \> 6;
• Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive);
• The patient is not planned or cannot undergo thrombectomy or intravenous thrombolysis in accordance with the current version of the Clinical Guidelines;
• Written informed consent from patients or their legally authorized representatives.
Locations
Other Locations
Russian Federation
Altai Regional Clinical Hospital
NOT_YET_RECRUITING
Barnaul
Chelyabinsk Regional Clinical Hospital No. 3
NOT_YET_RECRUITING
Chelyabinsk
Irkutsk Regional Clinical Hospital
NOT_YET_RECRUITING
Irkutsk
Kaluga Regional Clinical Hospital
NOT_YET_RECRUITING
Kaluga
Interregional Clinical and Diagnostic Center
NOT_YET_RECRUITING
Kazan'
S.V. Ochapovsky Research Institute - Regional Clinical Hospital No. 1
NOT_YET_RECRUITING
Krasnodar
N.I. Pirogov Russian National Research Medical University
NOT_YET_RECRUITING
Moscow
V.I. Voynov Orenburg Regional Clinical Hospital
RECRUITING
Orenburg
Ryazan Regional Clinical Hospital
NOT_YET_RECRUITING
Ryazan
Leningradskaya Regional Clinical Hospital
NOT_YET_RECRUITING
Saint Petersburg
Sergiev Posad District Hospital
NOT_YET_RECRUITING
Sergiyev Posad
Tver Regional Clinical Hospital
NOT_YET_RECRUITING
Tver'
Ulyanovsk Regional Clinical Hospital
NOT_YET_RECRUITING
Ulyanovsk
City Clinical Hospital of Emergency Medical Care No. 25
NOT_YET_RECRUITING
Volgograd
Sverdlovsk Regional Clinical Hospital No. 1
NOT_YET_RECRUITING
Yekaterinburg
Contact Information
Primary
Nikolay A. Shamalov, MD, prof
shamalovn@gmail.com
(499) 936-99-37
Backup
Natalya A. Marskaya
marskayana@gmail.com
(499) 936-99-37
Time Frame
Start Date:2026-06-09
Estimated Completion Date:2029-01-01
Participants
Target number of participants:990
Treatments
Experimental: 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