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

December 23, 2025 updated by: Supergene, LLC

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)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The current guidelines recommended intravenous thrombolysis as the first-line treatment for acute large vessel occlusion of anterior circulation stroke within 4.5 hours of stroke onset. However, a majority of patients arrive in the hospital outside the 4.5-hour time window, who could not receive intravenous thrombolysis.

In 2020, the non-immunogenic staphylokinase was registered in Russia for the acute ischemic stroke treatment within 4,5 h after the onset of symptoms. In the FRIDA randomized clinical trial the non-immunogenic staphylokinase was non-inferior to alteplase for patients with acute ischaemic stroke. Mortality, symptomatic intracranial haemorrhage, and serious adverse events did not differ significantly between groups. Non-immunogenic staphylokinase is easy to administer with a rapid single bolus of 10 mg regardless patients' bodyweight, simplifying clinical use. In 2024, the non-immunogenic staphylokinase has been included in the updated Russian clinical guidelines for the acute ischemic stroke treatment.

A rapid (10 s) single bolus of the non-immunogenic staphylokinase in patients with acute ischemic stroke may provide significant advantages over a one-hour alteplase administration in the more rapid reperfusion in the first 24 hours after thrombolysis and a greater number of good functional outcomes. It can be assumed that the non-immunogenic staphylokinase usage in patients with acute ischemic stroke outside the 4.5-hour therapeutic window will lead to the restoration of collateral blood flow in the penumbra in comparison with standard medical management.

Therefore, FRIDA-CT trial is aimed to investigate the efficacy and safety of the non-immunogenic staphylokinase within the time window of 4.5-24 hours, wake-up stroke or no witness stroke in patients who had an acute ischaemic stroke with salvageable tissue due to large vessel occlusion.

In the multicenter, double-blind, randomized, placebo-controlled phase III clinical trial patients who had an acute ischaemic stroke due to anterior circulation large vessel occlusion (internal carotid artery, middle cerebral artery M1 and M2 segments) within 4.5-24 hours from last known well (including wake-up stroke and no witness stroke) and with salvageable tissue (ischaemic core volume <70 mL, mismatch ratio ≥1.8 and mismatch volume ≥15 mL) based on CT perfusion or MRI perfusion-weighted imaging (PWI) will be included and randomised to the non-immunogenic staphylokinase, 10 mg (single bolus) regardless patient's bodyweight or placebo group. Patients who are intended for direct thrombectomy will be excluded from the trial. Follow-up period will be 90 days.

Study Type

Interventional

Enrollment (Estimated)

990

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nikolay A. Shamalov, MD, prof
  • Phone Number: +7 (499) 936-99-37
  • Email: shamalovn@gmail.com

Study Contact Backup

Study Locations

  • Russia
      • Barnaul, Russia, 656024
        • Altai Regional Clinical Hospital
        • Contact:
          • Sergey A. Fedyanin, PhD
          • Phone Number: +7 (3852) 68-97-41
          • Email: fedsa@bk.ru
        • Principal Investigator:
          • Sergey A. Fedyanin, PhD
      • Chelyabinsk, Russia
        • Chelyabinsk Regional Clinical Hospital No. 3
        • Contact:
        • Principal Investigator:
          • Dmitry V. Popov, PhD
      • Irkutsk, Russia, 664079
        • Irkutsk Regional Clinical Hospital
        • Contact:
        • Principal Investigator:
          • Ivan V. Korobeynikov, PhD
      • Kaluga, Russia, 248007
        • Kaluga Regional Clinical Hospital
        • Contact:
          • Ulukpan A. Elemanov, PhD
          • Phone Number: +7 (484) 240-33-03
          • Email: ulukpa@mail.ru
        • Principal Investigator:
          • Ulukpan A. Elemanov, PhD
      • Kazan', Russia, 420101
        • Interregional Clinical and Diagnostic Center
        • Contact:
        • Principal Investigator:
          • Dina R. Khasanova, MD, Prof
      • Krasnodar, Russia, 350086
        • S.V. Ochapovsky Research Institute - Regional Clinical Hospital No. 1
        • Contact:
        • Principal Investigator:
          • Ludmila V. Timchenko, MD, prof
      • Moscow, Russia, 117997
        • N.I. Pirogov Russian National Research Medical University
        • Contact:
        • Principal Investigator:
          • Larisa L. Korsunskaya, MD, Prof
      • Orenburg, Russia
        • V.I. Voynov Orenburg Regional Clinical Hospital
        • Contact:
        • Principal Investigator:
          • Alexandr N. Chirkov, PhD
      • Saint Petersburg, Russia, 194291
        • Leningradskaya Regional Clinical Hospital
        • Contact:
        • Principal Investigator:
          • Natalya V. Zhukovskaya, MD, prof
      • Sergiyev Posad, Russia, 141301
        • Sergiev Posad District Hospital
        • Contact:
          • Anton G. Koledinsky, MD, PhD
          • Phone Number: +7 (496) 542-22-84
          • Email: koledant@mail.ru
        • Principal Investigator:
          • Anton G. Koledinsky, MD, PhD
      • Tver', Russia, 170036
        • Tver Regional Clinical Hospital
        • Contact:
        • Principal Investigator:
          • Ksenia V. Khoroshavina
      • Ulyanovsk, Russia
        • Ulyanovsk Regional Clinical Hospital
      • Volgograd, Russia, 400138
        • City Clinical Hospital of Emergency Medical Care No. 25
        • Contact:
        • Principal Investigator:
          • Eduard A. Ponomarev, MD, prof
      • Yekaterinburg, Russia, 620102
        • Sverdlovsk Regional Clinical Hospital No. 1
        • Contact:
        • Principal Investigator:
          • Andrey M. Alasheev, MD, prof
    • Ryazan Oblast
      • Ryazan, Ryazan Oblast, Russia, 390039
        • Ryazan Regional Clinical Hospital
        • Contact:
        • Principal Investigator:
          • Sergei B. Aksentyev, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men and women aged 18 years and over;
  2. 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";
  3. Pre-stroke modified Rankin scale (mRS) score≤1;
  4. 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;
  5. Neuroimaging: target mismatch profile on CT or MRI perfusion: ischemic core volume <70 mL, mismatch ratio≥1.8 and mismatch volume≥15 mL;
  6. Alberta Stroke Program Early CT score (ASPECTS) > 6;
  7. Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive);
  8. The patient is not planned or cannot undergo thrombectomy or intravenous thrombolysis in accordance with the current version of the Clinical Guidelines;
  9. Written informed consent from patients or their legally authorized representatives.

Exclusion Criteria:

  1. Acute ischemic stroke within 4,5 h after symptom onset;
  2. Intended to proceed to endovascular treatment;
  3. Known hypersensitivity to the non-immunogenic staphylokinase;
  4. Convulsive seizures at the onset of the disease, if there is no certainty that the seizure is a clinical manifestation of acute ischemic stroke;
  5. Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg), and the inability to reduce systolic blood pressure below 180 mmHg or diastolic blood pressure below 105 mmHg;
  6. Blood glucose <2.8 or >22.2 mmol/L (after blood glucose level correction to the specified values, inclusion of the patient in the study is possible);
  7. Neuroimaging (CT, MRI) signs of intracranial hemorrhage, brain tumor, arteriovenous malformation, brain abscess, cerebral aneurysm;
  8. Subarachnoid hemorrhage;
  9. Major bleeding currently or within the past 6 months;
  10. Surgery on the brain or spinal cord in the last 2 months;
  11. Punctures of non-compressible arteries and veins in the last 7 days;
  12. Gastrointestinal or genitourinary bleeding in the last 3 weeks. Confirmed exacerbations of gastric ulcer and duodenal ulcer in the last 3 months;
  13. Platelet count below 100,000/mm3;
  14. Previous stroke or severe traumatic brain injury within 3 months;
  15. Unable to perform CT or MRI;
  16. History of hemorrhagic stroke or stroke of unspecified genesis;
  17. Multiple arterial occlusion (bilateral MCA occlusion, MCA occlusion accompanied with basilar occlusion);
  18. Concomitant use of indirect oral anticoagulants (warfarin) with INR > 1.7;
  19. Taking direct anticoagulants (heparin, heparinoids) in the previous 48 hours with an APTT value above normal;
  20. Taking new oral anticoagulants in the previous 48 hours with a thrombin time value above normal and the impossibility of administering the specific antagonist idarucizumab (for dabigatran) or the presence of anti-Xa activity (for rivaroxaban, apixaban and edoxaban).
  21. Severe liver disease, including liver failure, liver cirrhosis, portal hypertension (with esophageal varices), active hepatitis;
  22. Acute pancreatitis;
  23. Bacterial endocarditis, pericarditis;
  24. Arterial aneurysms, malformations of arteries and veins. Suspected dissecting aortic aneurysm;
  25. Cancer with an increased risk of bleeding;
  26. Major surgeries or severe injuries within the last 14 days, minor surgeries or invasive procedures within the last 10 days;
  27. Prolonged or traumatic cardiopulmonary resuscitation (more than 2 minutes);
  28. Hemorrhagic diathesis, including renal and hepatic failure;
  29. Data on bleeding or acute trauma (fracture) at the time of examination;
  30. Pregnant women, nursing mothers, or reluctant to use effective contraceptive measures during the period of trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo is given as a single intravenous bolus (within 5-10 seconds) immediately upon randomization
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
Drug: 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
Other Names:
  • Fortelyzin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Good functional outcome
Time Frame: 90 days
The number of patients with good functional outcome defined as an mRS score 0-1 at 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ordinal distribution of mRS
Time Frame: 90 days
Ordinal distribution of mRS at 90 days
90 days
Functional independence outcome
Time Frame: 90 days
The number of patients with functional independence defined by an mRS score 0-2 point at 90 days
90 days
NIHSS change from baseline
Time Frame: 7-14 days
NIHSS median change from baseline on discharge
7-14 days
The rate of improvement on reperfusion
Time Frame: 24 hours
The number of patients with recanalization of 2 and 3 points on the arterial occlusion scale (rAOL) 24 hours after drug administration according to CT (MRI) angiography, where 0 points - complete occlusion, 3 points - complete recanalization.
24 hours
All-cause mortality
Time Frame: 90 days
Rate of all-cause mortality within 90 days
90 days
Poor functional outcome
Time Frame: 90 days
The number of patients with poor functional outcome defined by an mRS score 5-6 point at 90 days
90 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemorrhagic transformation
Time Frame: 24 hours
Rate of hemorrhagic transformation according to The Heidelberg Bleeding Classification within 24 hours
24 hours
Symptomatic intracranial hemorrhage
Time Frame: 24 hours
Rate of symptomatic intracranial hemorrhage (sICH) (as defined by The European Cooperative Acute Stroke Study III criteria [ECASSIII] and Safe Implementation of Thrombolysis in Stroke-Monitoring Study [SITS-MOST]) within 24 hours
24 hours
Major bleeding
Time Frame: 90 days
Rate of major bleeding at 90 days (as defined by the Bleeding Academic Research Consortium (BARC) scale: type 3 and type 5)
90 days
Serious adverse events (SAEs)
Time Frame: 90 days
Rate of serious adverse events (SAEs) within 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Supergene, LLC

Investigators

  • Principal Investigator: Nikolay A. Shamalov, MD, prof, Federal Center for Brain and Neurotechnology of the Federal Medical and Biological Agency of Russia
  • Study Director: Sergey S. Markin, MD, prof, LLC "SuperGene"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

December 23, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRIDA-CT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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