Comparing a new thrombolytic treatment to surgery for acute limb ischemia
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
This study is testing a new treatment that uses a special medication to dissolve blood clots in the legs to see if it works better than surgery for people with acute limb ischemia.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Supergene, LLC Industry-sponsored |
| Locations | 8 sites (Kursk, Kursl Region and 7 other locations) |
| Trial ID | NCT05372718 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of intra-arterial administration of recombinant non-immunogenic staphylokinase (Fortelyzin®) in patients diagnosed with acute limb ischemia (ALI) compared to traditional surgical methods. The study aims to determine if this new thrombolytic agent can effectively dissolve blood clots in the lower extremities, potentially improving patient outcomes. Participants will be randomly assigned to receive either the new treatment or surgery, and their progress will be monitored for safety and effectiveness. The trial is designed to provide robust data on the benefits of this innovative approach in treating ALI.
Who should consider this trial
Good fit: Ideal candidates for this study are men and women aged 18 and older diagnosed with I-II b degree acute limb ischemia.
Not a fit: Patients with extensive bleeding, recent intracranial hemorrhage, or those who have undergone major surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce mortality and improve limb salvage rates in patients with acute limb ischemia.
How similar studies have performed: Previous studies have shown promising results with similar thrombolytic agents, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kursk, Kursl Region and 7 other locations
- Kursk city emergency hospital — Kursk, Kursl Region, Russia (Recruiting)
- Sergiyev Posad Regional Clinical Hospital — Sergiyev Posad, Moscow Oblast, Russia (Recruiting)
- Kaliningrad Regional Clinical Hospital — Kaliningrad, Russia (Recruiting)
- Kazan City Hospital No. 7 — Kazan', Russia (Recruiting)
- S.S. Yudin City clinical hospital — Moscow, Russia (Recruiting)
- S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center — Moscow, Russia (Recruiting)
- Ufa Emergency City Hospital — Ufa, Russia (Recruiting)
- Volgograd City Clinical Hospital of Emergency #25 — Volgograd, Russia (Recruiting)
Study contacts
- Principal investigator: Igor I. Zatevakhin, MD, PhD — N.I. Pirogov Russian Medical University, President of the Russian Society of Surgeons
- Study coordinator: Sergey S. Markin, MD, PhD
- Email: amsemenof@gmail.com
- Phone: (906) 796-89-06
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.