Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial
Recruiting now · Phase 3
Conditions studied: Acute Limb Ischemia
In brief
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.
Key facts
- Study ID
- NCT05372718
- Run by
- Supergene, LLC
- People needed
- 170
- Starts
- 2022-12-26
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-12-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Kursk city emergency hospital — Kursk, Kursl Region, Russia (enrolling)
- Sergiyev Posad Regional Clinical Hospital — Sergiyev Posad, Moscow Oblast, Russia (enrolling)
- Kaliningrad Regional Clinical Hospital — Kaliningrad, Russia (enrolling)
- Kazan City Hospital No. 7 — Kazan', Russia (enrolling)
- S.S. Yudin City clinical hospital — Moscow, Russia (enrolling)
- S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center — Moscow, Russia (enrolling)
- Ufa Emergency City Hospital — Ufa, Russia (enrolling)
- Volgograd City Clinical Hospital of Emergency #25 — Volgograd, Russia (enrolling)
Full record on ClinicalTrials.gov
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