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

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.

Timeline

Start

2022-12-26

Primary completion

2026-12-31

Completion

2026-12-31

Publications

• Results Gusev EI, Martynov MY, Nikonov AA, Shamalov NA, Semenov MP, Gerasimets EA, Yarovaya EB, Semenov AM, Archakov AI, Markin SS; FRIDA Study Group. Non-immunogenic recombinant staphylokinase versus alteplase for patients with acute ischaemic stroke 4.5 h after symptom onset in Russia (FRIDA): a randomised, open label, multicentre, parallel-group, non-inferiority trial. Lancet Neurol. 2021 Sep;20(9):721-728. doi: 10.1016/S1474-4422(21)00210-6.
• Zatevakhin II, Chupin AV, Karpenko AA, Savello AV, Zolkin VN, Yarovaya EB, Kutsenko VA, Ivanov SV, Semenov MP, Semenov AM, Markin SS. [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]. Angiol Sosud Khir. 2025 Jun 2;31(2):33-41. doi: 10.33029/1027-6661-2025-31-2-33-41. Russian.

Drugs

Indications