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

NCT07324837 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: FRIDA-CT
• Study Type: interventional
• Target: 990
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Ischemic Stroke, Acute

Keywords

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Good functional outcome

  The number of patients with good functional outcome defined as an mRS score 0-1 at 90 days

  90 days

Secondary Outcomes (6)

• Ordinal distribution of mRS

  90 days

• Functional independence outcome

  90 days

• NIHSS change from baseline

  7-14 days

• The rate of improvement on reperfusion

  24 hours

• All-cause mortality

  90 days

Other Outcomes (4)

• Hemorrhagic transformation

  24 hours

• Symptomatic intracranial hemorrhage

  24 hours

• Major bleeding

  90 days

Study Arms (2)

Non-immunogenic staphylokinase

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Placebo DRUG

Placebo is given as a single intravenous bolus (within 5-10 seconds) immediately upon randomization

Placebo

non-immunogenic staphylokinase DRUG

The non-immunogenic staphylokinase is given as a single intravenous bolus, 10 mg (within 5-10 seconds) immediately upon randomization regardless patient's bodyweight

Also known as: Fortelyzin®

Non-immunogenic staphylokinase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Acute ischemic stroke within 4,5 h after symptom onset;
• Intended to proceed to endovascular treatment;
• Known hypersensitivity to the non-immunogenic staphylokinase;
• Convulsive seizures at the onset of the disease, if there is no certainty that the seizure is a clinical manifestation of acute ischemic stroke;
• 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;
• Neuroimaging (CT, MRI) signs of intracranial hemorrhage, brain tumor, arteriovenous malformation, brain abscess, cerebral aneurysm;
• Subarachnoid hemorrhage;
• Major bleeding currently or within the past 6 months;
• Surgery on the brain or spinal cord in the last 2 months;
• Punctures of non-compressible arteries and veins in the last 7 days;
• Gastrointestinal or genitourinary bleeding in the last 3 weeks. Confirmed exacerbations of gastric ulcer and duodenal ulcer in the last 3 months;
• Platelet count below 100,000/mm3;
• Previous stroke or severe traumatic brain injury within 3 months;
• Unable to perform CT or MRI;
• History of hemorrhagic stroke or stroke of unspecified genesis;

Sponsors & Collaborators

• Supergene, LLC: lead

Study Sites (15)

Ryazan Regional Clinical Hospital

Ryazan, Ryazan Oblast, 390039, Russia

Location

Altai Regional Clinical Hospital

Barnaul, 656024, Russia

Location

Chelyabinsk Regional Clinical Hospital No. 3

Chelyabinsk, Russia

Location

Irkutsk Regional Clinical Hospital

Irkutsk, 664079, Russia

Location

Kaluga Regional Clinical Hospital

Kaluga, 248007, Russia

Location

Interregional Clinical and Diagnostic Center

Kazan', 420101, Russia

Location

S.V. Ochapovsky Research Institute - Regional Clinical Hospital No. 1

Krasnodar, 350086, Russia

Location

N.I. Pirogov Russian National Research Medical University

Moscow, 117997, Russia

Location

V.I. Voynov Orenburg Regional Clinical Hospital

Orenburg, Russia

Location

Leningradskaya Regional Clinical Hospital

Saint Petersburg, 194291, Russia

Location

Sergiev Posad District Hospital

Sergiyev Posad, 141301, Russia

Location

Tver Regional Clinical Hospital

Tver', 170036, Russia

Location

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, Russia

Location

City Clinical Hospital of Emergency Medical Care No. 25

Volgograd, 400138, Russia

Location

Sverdlovsk Regional Clinical Hospital No. 1

Yekaterinburg, 620102, Russia

Location

Related Publications (2)

• Gusev EI, Martynov MY, Nikonov AA, Shamalov NA, Semenov MP, Gerasimets EA, Yarovaya EB, Semenov AM, Archakov AI, Markin SS; FRIDA Study Group. Non-immunogenic recombinant staphylokinase versus alteplase for patients with acute ischaemic stroke 4.5 h after symptom onset in Russia (FRIDA): a randomised, open label, multicentre, parallel-group, non-inferiority trial. Lancet Neurol. 2021 Sep;20(9):721-728. doi: 10.1016/S1474-4422(21)00210-6.

  PMID: 34418399 RESULT

• Shamalov NA, Martynov MY, Yarovaya EB, Chefranova ZY, Kutsenko VA, Semenov AM, Ivanov SV, Semenov MP, Markin SS, Gusev EI; FORPI Study Group. Thrombolysis With the Non-Immunogenic Staphylokinase for Acute Ischemic Stroke in the FORPI Registry: An Observational Study. Stroke. 2026 Feb;57(2):394-403. doi: 10.1161/STROKEAHA.125.051115. Epub 2025 Nov 26.

  PMID: 41293810 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nikolay A. Shamalov, MD, prof

  Federal Center for Brain and Neurotechnology of the Federal Medical and Biological Agency of Russia

  PRINCIPAL INVESTIGATOR

• Sergey S. Markin, MD, prof

  LLC "SuperGene"

  STUDY DIRECTOR

Central Study Contacts

Nikolay A. Shamalov, MD, prof

CONTACT

(499) 936-99-37; shamalovn@gmail.com

Natalya A. Marskaya

CONTACT

(499) 936-99-37; marskayana@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 8, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (15)