NCT07324837

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
990

participants targeted

Target at P75+ for phase_3

Timeline
29mo left

Started Jun 2026

Typical duration for phase_3

Geographic Reach
1 country

22 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Jun 2026Jan 2029

First Submitted

Initial submission to the registry

December 23, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

June 9, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

2.4 years

First QC Date

December 23, 2025

Last Update Submit

July 22, 2026

Conditions

Ischemic Stroke, Acute

Keywords

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Excellent functional outcome

    The number of patients with excellent 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

  • +1 more secondary outcomes

Other Outcomes (4)

  • Hemorrhagic transformation

    24 hours

  • Symptomatic intracranial hemorrhage

    24 hours

  • Major bleeding

    90 days

  • +1 more other outcomes

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

PlaceboDRUG

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

Placebo
non-immunogenic staphylokinaseDRUG

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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;
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Ryazan Regional Clinical Hospital

Ryazan, Ryazan Oblast, 390039, Russia

NOT YET RECRUITING

Altai Regional Clinical Hospital

Barnaul, 656024, Russia

NOT YET RECRUITING

Chelyabinsk Regional Clinical Hospital No. 3

Chelyabinsk, Russia

NOT YET RECRUITING

Irkutsk Regional Clinical Hospital

Irkutsk, 664079, Russia

RECRUITING

Kaluga Regional Clinical Hospital

Kaluga, 248007, Russia

NOT YET RECRUITING

Interregional Clinical and Diagnostic Center

Kazan', 420101, Russia

NOT YET RECRUITING

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

Krasnodar, 350086, Russia

RECRUITING

Krasnogorsk Clinical Hospital

Krasnogorsk, 143408, Russia

NOT YET RECRUITING

F.I. Inozemtsev Moscow City Clinical Hospital

Moscow, 105187, Russia

NOT YET RECRUITING

Moscow Multidisciplinary Clinical Center "Kommunarka"

Moscow, 108814, Russia

NOT YET RECRUITING

N.I. Pirogov Russian National Research Medical University

Moscow, 117997, Russia

NOT YET RECRUITING

L.A. Vorokhobov Moscow City Clinical Hospital No. 67

Moscow, 123423, Russia

NOT YET RECRUITING

A.K. Yeramishantsev Moscow City Clinical Hospital

Moscow, 129327, Russia

NOT YET RECRUITING

N.A. Semashko Nizhny Novgorod Regional Clinical Hospital

Nizhny Novgorod, 603126, Russia

NOT YET RECRUITING

V.I. Voynov Orenburg Regional Clinical Hospital

Orenburg, Russia

RECRUITING

St. Petersburg Hospital for War Veterans

Saint Petersburg, 193079, Russia

RECRUITING

Leningradskaya Regional Clinical Hospital

Saint Petersburg, 194291, Russia

RECRUITING

Sergiev Posad District Hospital

Sergiyev Posad, 141301, Russia

NOT YET RECRUITING

Tver Regional Clinical Hospital

Tver', 170036, Russia

RECRUITING

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, Russia

RECRUITING

City Clinical Hospital of Emergency Medical Care No. 25

Volgograd, 400138, Russia

NOT YET RECRUITING

Sverdlovsk Regional Clinical Hospital No. 1

Yekaterinburg, 620102, Russia

RECRUITING

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: 34418399RESULT

  • 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: 41293810RESULT

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular 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) 936-99-37shamalovn@gmail.com

Natalya A. Marskaya

CONTACT

(499) 936-99-37marskayana@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

June 9, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

The funder of the study is committed to the responsible sharing of data from FRIDA-CT trail. Data will be provided to any qualified investigator on reasonable request. Deidentified participant data will be available after the publication of the results of the completed study on request to the corresponding author.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
within 90 days after request
Access Criteria
Proposals will be reviewed and approved by the funder and Data and Safety Monitoring Board. Once the proposal has been approved, data can be transferred through a secure online platform after the signing of a data access agreement and a confidentiality agreement.

Locations

RU(22)