Status:
RECRUITING
Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial
Lead Sponsor:
Supergene, LLC
Conditions:
Acute Limb Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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)...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT05372718
Start Date
December 26 2022
End Date
December 31 2026
Last Update
December 1 2025
Active Locations (8)
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1
Kursk city emergency hospital
Kursk, Kursl Region, Russia, 305035
2
Sergiyev Posad Regional Clinical Hospital
Sergiyev Posad, Moscow Oblast, Russia, 141301
3
Kaliningrad Regional Clinical Hospital
Kaliningrad, Russia, 236016
4
Kazan City Hospital No. 7
Kazan', Russia, 420103