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

Multicenter, Open-label, Randomized Clinical Trial of Efficacy and Safety of the Thrombolysis With Recombinant Non-immunogenic Staphylokinase (Fortelyzin®) in Patients With ALI vs Surgery

Sponsors

Lead Sponsor: Supergene, LLC

Source Supergene, LLC
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.

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.

Overall Status Not yet recruiting
Start Date 2022-06-01
Completion Date 2025-07-01
Primary Completion Date 2025-05-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of patients without amputations 30 days post randomization
Enrollment 170
Condition
Intervention

Intervention Type: Drug

Intervention Name: Recombinant non-immunogenic staphylokinase (Fortelyzin®)

Description: lyophilisate for preparation a solution

Arm Group Label: Recombinant non-immunogenic staphylokinase

Other Name: Fortelyzin®

Intervention Type: Procedure

Intervention Name: surgical methods of treatment

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

Arm Group Label: Surgical methods of treatment

Eligibility

Criteria:

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: - 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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Contact: Investigator:
Kazan State Medical University | Kazan, Republic Of Tatarstan, 420012, Russian Federation Ivan I. Klushkin, MD, PhD (843) 223-04-13 +7 [email protected] Ivan I. Klushkin, MD, PhD Principal Investigator
Federal Scientific and Clinical Center for Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency | Moscow, 123182, Russian Federation Troitskiy V. Alexander, MD, PhD (495) 395-61-97 +7 [email protected] Troitskiy V. Alexander, MD, PhD Principal Investigator
Rostov State Medical University | Rostov-on-Don, 344022, Russian Federation Igor I. Prostov, PhD (863) 250-40-75 +7 [email protected] Igor I. Prostov, PhD Principal Investigator
Tver Regional Clinical Hospital | Tver, 170036, Russian Federation Vladimir V. Bobkov, PhD 4822775454 +7 [email protected] Vladimir V. Bobkov, PhD Principal Investigator
Volgograd City Clinical Hospital of Emergency #25 | Volgograd, 400138, Russian Federation Eduard A. Ponomarev, MD, PhD 8442585426 +7 [email protected] Eduard A. Ponomarev, MD, PhD Principal Investigator
Location Countries

Russian Federation

Verification Date

2022-05-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Recombinant non-immunogenic staphylokinase

Type: Experimental

Description: 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.

Label: Surgical methods of treatment

Type: Experimental

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

Acronym FORAT
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

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

Primary Purpose: Treatment

Masking: None (Open Label)

Masking Description: Open-label

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