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

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

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) in comparison with surgical methods of treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Supergene, LLC

Criteria

Inclusion Criteria:

• Men and women aged 18 and over;

• 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