Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial

NCT05372718 | Recruiting Phase 3

• 1 other identifier: FORAT
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 8

Brief Summary

Objective: to evaluate the efficacy and safety of intra-arterial intrathrombus administration of the recombinant non-immunogenic staphylokinase (Fortelyzin®) in patients with acute limb ischemia (ALI) vs surgery.

Conditions

Acute Limb Ischemia

Keywords

acute limb ischemia; thrombolysis; thrombosis

Outcome Measures

Primary Outcomes (1)

• Number of patients without amputations

  Outcome Measure is evaluated in terms of the number of patients without amputations

  30 days post randomization

Other Outcomes (4)

• Safety endpoint - Death from all causes

  30 days post randomization

• Safety endpoint - hemorrhagic stroke

  30 days post randomization

• Safety endpoint - BARC type 3 and 5 bleeding

  30 days post randomization

Study Arms (2)

Recombinant non-immunogenic staphylokinase

EXPERIMENTAL

lyophilisate for preparation a solution, 5 mg (745,000 IU) in 20 ml over 1 minute through a perforated multihole catheter intrathrombally. 30 minutes after this injection, infusion of recombinant non-immunogenic staphylokinase will be continued at a dose of 1 mg/hour, maximum 10 mg (50 ml) for 10 hours through a perforated multihole catheter intrathrombally.

Drug: Recombinant non-immunogenic staphylokinase (Fortelyzin®)

Surgical methods of treatment

EXPERIMENTAL

endovascular intervention, open surgery and/or bypass surgery in accordance with the current National Guidelines

Procedure: surgical methods of treatment

Interventions

Recombinant non-immunogenic staphylokinase (Fortelyzin®) DRUG

lyophilisate for preparation a solution

Also known as: Fortelyzin®

Recombinant non-immunogenic staphylokinase

surgical methods of treatment PROCEDURE

Endovascular intervention, open surgery and/or bypass surgery in accordance with the current National Guidelines

Surgical methods of treatment

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 and older;
• Diagnosis of I-II b degree of ALI;
• Patient consent to use reliable contraceptive methods throughout the study and for 3 weeks after:
• women who have a negative pregnancy test and use the following contraceptives: intrauterine devices, oral contraceptives, contraceptive patch, prolonged injectable contraceptives, double barrier method of contraception. Women who are not fertile can also take part in the study (documented conditions: hysterectomy, tubal ligation, infertility, menopause for more than 1 year);
• men using barrier contraception. The study may also involve men who are not fertile (documented conditions: vasectomy, infertility);
• Availability of signed and dated informed consent of the patient to participate in the study.

You may not qualify if:

• Extensive bleeding at present;
• Intracranial (including subarachnoid) hemorrhage at present;
• Recent gastrointestinal bleeding (within 10 days);
• Major surgery or major trauma within the previous 3 months, recent traumatic brain injury;
• Systolic blood pressure above 180 mm Hg or diastolic blood pressure above 110 mm Hg or the need for intravenous drugs to lower blood pressure to these limits;
• Pregnancy, lactation;
• Known hypersensitivity to Fortelyzin®;
• Platelet count less than 100,000/µL

Sponsors & Collaborators

• Supergene, LLC: lead

Study Sites (8)

Kursk city emergency hospital

Kursk, Kursl Region, 305035, Russia

RECRUITING

Sergiyev Posad Regional Clinical Hospital

Sergiyev Posad, Moscow Oblast, 141301, Russia

RECRUITING

Kaliningrad Regional Clinical Hospital

Kaliningrad, 236016, Russia

RECRUITING

Kazan City Hospital No. 7

Kazan', 420103, Russia

RECRUITING

S.S. Yudin City clinical hospital

Moscow, 115446, Russia

RECRUITING

S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center

Moscow, 125284, Russia

RECRUITING

Ufa Emergency City Hospital

Ufa, 450092, Russia

RECRUITING

Volgograd City Clinical Hospital of Emergency #25

Volgograd, 400138, Russia

RECRUITING

Related Publications (1)

• 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

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Igor I. Zatevakhin, MD, PhD

  N.I. Pirogov Russian Medical University, President of the Russian Society of Surgeons

  PRINCIPAL INVESTIGATOR

• Sergey S. Markin, MD, PhD

  Supergene, LLC

  STUDY DIRECTOR

Central Study Contacts

Sergey S. Markin, MD, PhD

CONTACT

(906) 796-89-06; amsemenof@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: At clinical centers, patients will be randomly distributed by the "envelope method" into two groups for assignation Fortelyzin® or surgical methods of treatment.

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 13, 2022
• Study Start: December 26, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (8)