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

Launched by SUPERGENE, LLC · May 12, 2022

Keywords

ClinConnect Summary

The FORAT Trial is a clinical study looking at a new treatment option for patients with acute limb ischemia (ALI), a serious condition where blood flow to the limbs is suddenly reduced, which can cause pain and potential tissue damage. The trial is comparing the effectiveness and safety of a drug called Fortelyzin® with traditional surgery to see which method works better for helping patients recover blood flow to their limbs.

To participate in this trial, individuals must be at least 18 years old and diagnosed with a specific level of ALI. They should also be able to agree to use reliable birth control methods during the study. Participants will receive either the new drug or surgery and will be monitored closely for their health and recovery. It's important to note that some individuals won't be eligible, such as those with certain bleeding issues, recent surgeries, or specific health conditions. If you or a family member are interested in this trial, it could be a chance to receive potentially beneficial treatment while contributing to important medical research.

Gender

ALL

Eligibility criteria

• 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