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
Supergene, LLC
170 participants
Dec 26, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria8
- 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
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Interventions
lyophilisate for preparation a solution
Endovascular intervention, open surgery and/or bypass surgery in accordance with the current National Guidelines
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05372718