Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Li… (NCT05372718) | Clinical Trial Compass
RecruitingPhase 3
Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial
Russia170 participantsStarted 2022-12-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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