Intraarterial intrathrombus thrombolysis with non-immunogenic staphylokinase vs surgery in patients with acute limb ischemia: protocol of a multicenter, open-label, randomized clinical trial FORAT
AbstractObjective. The aim of the FORAT clinical trial is to evaluate the efficacy and safety of intra-arterial intrathrombus administration of recombinant non-immunogenic staphylokinase in patients with acute limb ischemia vs surgery.
Patients and methods. Non-immunogenic staphylokinase has high thrombolytic activity and fibrin selectivity. The FORAT clinical trial is a randomized, open-label, multicenter, comparative study in two parallel groups. At the clinical sites, eligible patients (with a recruitment target of 170 subjects, taking into account a possible 10% dropout) diagnosed as having grade I-IIb acute limb ischemia will be equally randomized by the “envelope” method into two groups assigned to receive either non-immunogenic staphylokinase or undergo surgical intervention. Surgical methods of treatment are taken to mean the possibility of endovascular intervention, open surgery and/or bypass surgery in accordance with the current National Guidelines, depending on the accepted tactics of patient management in the clinical center and the patient’s condition.
The study protocol presents the inclusion and exclusion criteria, sample size estimation, and the plan of the trial. The primary efficacy endpoint is the number of patients without amputations at day 30. Safety criteria will be defined as cases of hemorrhagic stroke, bleeding according to the BARC criteria (types 3 and 5), the incidence of adverse events and lethal outcomes within 30 days of follow-up.
Results. Based on the results of the study, data will be obtained on the efficacy and safety of intra-arterial thrombolysis administration of non-immunogenic staphylokinase in patients with acute limb versus surgical methods of treatment. A report will be drawn up with attachments of individual data and statistical analysis of the results. The findings of the study will be published and presented at conferences.
Registration. The FORAT trial protocol was approved by the Ministry of Health of Russia No. 184 dated March 18, 2022, the Ethics Council of the Ministry of Health of Russia No. 303 dated March 1, 2022, and registered at clinicaltrials.gov No. NCT05372718 (FORAT).
Keywords: lower extremity arterial thrombosis; acute limb ischemia; thrombolysis; non-immunogenic staphylokinase
Funding. The trial is financially supported by the Russian Academy of Sciences, Department of Medical Sciences, with the study drug (non-immunogenic staphylokinase) provided by the Limited Liability Company “SupraGen”.
Conflict of interest. The authors declare no conflicts of interest.
Authors’ contribution. Study conception and design – Zatevakhin I.I., Chupin A.V., Karpenko A.A., Zolkin V.N.; statistical processing – Yarovaya E.B., Kutsenko V.A.; draft manuscript preparation – Markin S.S., Semenov M.P., Semenov A.M., Ivanov S.V.; manuscript revision – Savello A.V., Zatevakhin I.I.
For citation: Zatevakhin I.I., Chupin A.V., Karpenko A.A., Savello A.V., Zolkin V.N., Yarovaya E.B., Kutsenko V.A., Ivanov S.V., Semenov M.P., Semenov A.M., Markin S.S. Intraarterial intrathrombus thrombolysis with non-immunogenic staphylokinase vs surgery in patients with acute limb ischemia: protocol of a multicenter, open-label, randomized clinical trial FORAT. Angiology and Vascular Surgery. Journal named after Academician A.V. Pokrovsky. 2025; 31 (2): 33–41. DOI: https://doi.org/10.33029/1027-6661-2025-31-2-33-41
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