CompletedNCT05372718FORATUpdated Oct 5, 2026

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

A Phase 3 interventional study of Recombinant non-immunogenic staphylokinase (Fortelyzin®) and surgical methods of treatment in Acute Limb Ischemia, sponsored by Supergene, LLC. Completed at 8 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Supergene, LLC · Phase 3, Interventional, and Treatment

Updated Oct 5, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓

Phase: Phase 3
Study type: Interventional
Enrollment: 170
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the detailed description

Fortelyzin® (the active substance Forteplase) is a recombinant non-immunogenic staphylokinase with high fibrinselective thrombolytic activity. In a multicentre, randomised clinical trial in patients with ST-segment elevation myocardial infarction (FRIDOM), non-immunogenic staphylokinase was administered as a single intravenous bolus of 15 mg in all patients, regardless of bodyweight, and showed similar high reperfusion patency and fewer minor bleeding events compared with tenecteplase, as well as the absence of neutralising IgGs. Results of the multicentre, randomised clinical trial in patients with an acute ischaemic stroke (FRIDA) suggested that the non-immunogenic staphylokinase administrated as a single intravenous bolus of 10 mg in all patients within the 4-5 h after the onset of symptoms is non-inferior to alteplase. Mortality, symptomatic intracranial haemorrhage, and serious adverse events did not differ between treatment groups.

Mortality in the ALI continues to be high. According to the Guidelines on the management of patients with ALI, intravenous systemic thrombolysis is ineffective in patients with this condition. In contrast, catheter-directed thrombolysis based on the principle that activation of fibrin-bound plasminogen to the active enzyme plasmin is the most effective approach of lysing pathologic thrombi in the lower extremities of I-II b degree of ALI (Evidence level I-A).

So the main objective of this study is to evaluate the efficacy and safety of intra-arterial intrathrombus administration of the recombinant non-immunogenic staphylokinase (Fortelyzin®) in patients with ALI vs surgery.

Conditions studied

Acute Limb Ischemia

Browse trials for

Thrombosis 1,506

Keywords

acute limb ischemia
thrombolysis
thrombosis

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 170 is above the median of 106 across 849 interventional studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Supergene, LLC is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 170 participants (actual)

Study arms

Experimental
Recombinant non-immunogenic staphylokinase
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®)
Experimental
Surgical methods of treatment
endovascular intervention, open surgery and/or bypass surgery in accordance with the current National Guidelines
Procedure: surgical methods of treatment

Interventions

DrugRecombinant non-immunogenic staphylokinase (Fortelyzin®)
lyophilisate for preparation a solution
Also known as: Fortelyzin®
Proceduresurgical methods of treatment
Endovascular intervention, open surgery and/or bypass surgery in accordance with the current National Guidelines

What researchers measure

Primary outcomes

Number of patients without amputations
Outcome Measure is evaluated in terms of the number of patients without amputations
Time frame: 30 days post randomization

Other outcomes

Safety endpoint - Death from all causes
The safety is evaluated in terms of the number of deaths from all causes
Time frame: 30 days post randomization
Safety endpoint - hemorrhagic stroke
The safety is evaluated in terms of the number of hemorrhagic stroke
Time frame: 30 days post randomization
Safety endpoint - BARC type 3 and 5 bleeding
The safety is evaluated in terms of the number of BARC type 3 and 5 bleeding
Time frame: 30 days post randomization
Safety endpoint - Number and severity of serious adverse events (SAEs) and AEs in organs and systems
The safety is evaluated in terms of the number and severity of SAEs and AEs in organs and systems
Time frame: 30 days post randomization

Study locations

8 sites

Kursk city emergency hospital
Kursk, Kursl Region 305035, Russia
Sergiyev Posad Regional Clinical Hospital
Sergiyev Posad, Moscow Oblast 141301, Russia
Kaliningrad Regional Clinical Hospital
Kaliningrad, 236016, Russia
Kazan City Hospital No. 7
Kazan', 420103, Russia
S.S. Yudin City clinical hospital
Moscow, 115446, Russia
S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center
Moscow, 125284, Russia
Ufa Emergency City Hospital
Ufa, 450092, Russia
Volgograd City Clinical Hospital of Emergency #25
Volgograd, 400138, Russia

References and documents

Publications

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. PubMed 34418399 ↗
Zatevakhin II, Chupin AV, Karpenko AA, Savello AV, Zolkin VN, Yarovaya EB, Kutsenko VA, Ivanov SV, Semenov MP, Semenov AM, Markin SS. [Intraarterial intrathrombus thrombolysis with non-immunogenic staphylokinase vs surgery in patients with acute limb ischemia: protocol of a multicenter, open-label, randomized clinical trial FORAT]. Angiol Sosud Khir. 2025 Jun 2;31(2):33-41. doi: 10.33029/1027-6661-2025-31-2-33-41. Russian. PubMed 41805599 ↗

Individual participant data

Plan to share: No

Updates

1 registry update since Sep 25, 2026

Status

Recruiting→Completed

changed Oct 5, 2026

Primary completion

Dec 31, 2026→Sep 30, 2026 (actual)

Oct 5, 2026

Study completion

Dec 31, 2026→Sep 30, 2026 (actual)

Oct 5, 2026

Show all 1 update

Oct 5, 2026
Recruiting→Completed
Primary completion Dec 31, 2026→Sep 30, 2026 (now actual)
Study completion Dec 31, 2026→Sep 30, 2026 (now actual)
+ 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05372718
Lead sponsor: Supergene, LLC
Responsible party: Sponsor
First posted: May 13, 2022
Start date: Dec 26, 2022
Primary completion: Sep 30, 2026
Completion: Sep 30, 2026
Last update: Oct 5, 2026

Study contacts

Igor I. Zatevakhin, MD, PhD

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

Sergey S. Markin, MD, PhD

study director · Supergene, LLC

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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