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Fortelyzin in the treatment of minor acute ischemic stroke according to a subanalysis of the observational study FORPI registry

https://doi.org/10.14412/2074-2711-2026-2-45-53

Abstract

    The question of whether intravenous thrombolytic therapy (ITT) is appropriate for patients with a minor stroke (NIHSS score < 5) remains a matter of debate. Fortelysin is a thrombolytic agent used to treat ischemic stroke.

   Objective: to assess the safety and efficacy of Fortelyzin in patients who have suffered a minor stroke in real-world clinical practice, based on data from a subanalysis of the FORPI registry.

   Material and methods. The FORPI registry is an open-label, prospective, non-interventional, observational study of Fortelyzin in patients with acute ischemic stroke. We analyzed the safety and efficacy of Fortelyzin in a group of patients with minor stroke characterized by an NIHSS < 5. Safety outcomes were the number of symptomatic intracranial hemorrhage (sICH) according to ECASS III and SITS-MOST definitions, as well as all-cause mortality at day 90. The efficacy outcome was a functional independence, defined by modified Rankin scale (mRS) score of 0–2 points at day 90.

   Results. The analysis included 836 patients with an NIHSS < 5 points. The median age was 64 [56; 72] years, and the median NIHSS score at admission was 4 [3; 4] points. SICH according to ECASS III definition was observed in three patients of 836 (0.4 %), and according to SITS-MOST definition, in four patients of 836 (0.5 %). All-cause mortality at day 90 was 2.2 % (18/836). The proportion of patients with functional independence (mSR of 0–2 points) at day 90 reached in 88 % (737/836) of patients.

   Conclusion. The FORPI registry provides compelling evidence that early intensive rehabilitation using Fortelyzin is characterised by a high level of safety and efficacy in patients who have suffered a minor stroke.

About the Authors

N. A. Shamalov
N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia; Federal Center of Brain and Neurotechnologies, FMBA of Russia
Russian Federation

Nikolay Anatolyevich Shamalov

117997; 1, Ostrovityanova St.; 1, Ostrovityanova St., Build. 10; Moscow
Competing Interests:

There are no conflicts of interest. The authors are solely responsible for submitting the final version of the manuscript for publication. All the authors have participated in developing the concept of the article and in writing the manuscript. The final version of the manuscript has been approved by all the authors



M. Yu. Martynov
N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia; Federal Center of Brain and Neurotechnologies, FMBA of Russia
Russian Federation

117997; 1, Ostrovityanova St.; 1, Ostrovityanova St., Build. 10; Moscow
Competing Interests:

There are no conflicts of interest. The authors are solely responsible for submitting the final version of the manuscript for publication. All the authors have participated in developing the concept of the article and in writing the manuscript. The final version of the manuscript has been approved by all the authors



N. A. Marskaya
N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia
Russian Federation

117997; 1, Ostrovityanova St.; Moscow
Competing Interests:

There are no conflicts of interest. The authors are solely responsible for submitting the final version of the manuscript for publication. All the authors have participated in developing the concept of the article and in writing the manuscript. The final version of the manuscript has been approved by all the authors



D. R. Khasanova
Kazan State Medical University, Ministry of Health of Russia
Russian Federation

420012; 49, Butlerova St.; Kazan
Competing Interests:

There are no conflicts of interest. The authors are solely responsible for submitting the final version of the manuscript for publication. All the authors have participated in developing the concept of the article and in writing the manuscript. The final version of the manuscript has been approved by all the authors



E. B. Yarovaya
M.V. Lomonosov Moscow State University
Russian Federation

119991; 1, Leninskie Gory; Moscow
Competing Interests:

There are no conflicts of interest. The authors are solely responsible for submitting the final version of the manuscript for publication. All the authors have participated in developing the concept of the article and in writing the manuscript. The final version of the manuscript has been approved by all the authors



I. A. Voznuk
Acad. I.P. Pavlov First Saint Petersburg State Medical University, Ministry of Health of Russia
Russian Federation

197022; 6-8, L'va Tolstogo St.; St. Petersburg
Competing Interests:

There are no conflicts of interest. The authors are solely responsible for submitting the final version of the manuscript for publication. All the authors have participated in developing the concept of the article and in writing the manuscript. The final version of the manuscript has been approved by all the authors



L. V. Timchenko
Research Institute – S.V. Ochapovsky Regional Clinical Hospital No. 1
Russian Federation

350086; 167, 1 Maya St.; Krasnodar
Competing Interests:

There are no conflicts of interest. The authors are solely responsible for submitting the final version of the manuscript for publication. All the authors have participated in developing the concept of the article and in writing the manuscript. The final version of the manuscript has been approved by all the authors



A. M. Alasheev
Sverdlovsk State Regional Clinical Hospital No 1
Russian Federation

620102; 185, Volgogradskaya St.; Yekaterinburg 
Competing Interests:

There are no conflicts of interest. The authors are solely responsible for submitting the final version of the manuscript for publication. All the authors have participated in developing the concept of the article and in writing the manuscript. The final version of the manuscript has been approved by all the authors



N. V. Khalo
I.S. Berzon Krasnoyarsk Interdistrict Clinical Hospital No. 20
Russian Federation

660123; 12, Instrumentalnaya St.; Krasnoyarsk
Competing Interests:

There are no conflicts of interest. The authors are solely responsible for submitting the final version of the manuscript for publication. All the authors have participated in developing the concept of the article and in writing the manuscript. The final version of the manuscript has been approved by all the authors



M. D. Bogatyreva
Stavropol Regional Clinical Hospital
Russian Federation

355029; 1, Semashko St.; Stavropol
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D. S. Khan
Primorsky Regional Clinical Hospital No. 1
Russian Federation

690091; 57, Aleutskaya St.; Vladivostok
Competing Interests:

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L. L. Korsunskaya
V.I. Vernadsky Crimean Federal University
Russian Federation

295007; 4, Akademika Vernadskogo Prosp.; Simferopol
Competing Interests:

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V. N. Nesterova
N.A. Semashko Nizhny Novgorod Regional Clinical Hospital
Russian Federation

603093; 190, Rodionova St.; Nizhny Novgorod
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Zh. Yu. Chefranova
Belgorod State National Research University
Russian Federation

308015; 85, Pobedy St.; Belgorod
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T. V. Kharitonova
I.I. Dzhanelidze St. Petersburg Research Institute of Emergency Medicine
Russian Federation

192242; 3, Budapeshtskaya St., lit. A; Saint Petersburg
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M. V. Sutormin
M.F. Vladimirsky Moscow Regional Research Clinical Institute
Russian Federation

129110; 61/2, Shchepkina St.; Moscow
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O. E. Furman
M.F. Vladimirsky Moscow Regional Research Clinical Institute
Russian Federation

129110; 61/2, Shchepkina St.; Moscow
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A. A. Kulesh
Acad. E.A. Vagner Perm State Medical University, Ministry of Health of Russia; City Clinical Hospital Four
Russian Federation

614990; 26, Petropavlovskaya St.; 614107; 2, KIM St.; Perm
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There are no conflicts of interest. The authors are solely responsible for submitting the final version of the manuscript for publication. All the authors have participated in developing the concept of the article and in writing the manuscript. The final version of the manuscript has been approved by all the authors



N. V. Zhukovskaya
Leningrad Regional Clinical Hospital
Russian Federation

194291; 45/2, Lunacharskogo Prosp.; St. Petersburg
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K. V. Khoroshavina
Tver Regional Clinical Hospital
Russian Federation

170036; 105, Peterburgskoe Sh.; Tver
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I. V. Korobeynikov
0Irkutsk Regional Clinical Hospital, winner of the “Mark of the Honor” award
Russian Federation

664049; 100, Yubileyny Microdistrict; Irkutsk
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O. V. Androphagina
V.D. Seredavin Samara Regional Clinical Hospital
Russian Federation

443095; 159, Tashkentskaya St.; Samara
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A. A. Bulanov
N.N. Burdenko Penza Regional Clinical Hospital
Russian Federation

440026; 28, Lermontova St.; Penza
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D. N. Shamalova
Federal Center of Brain and Neurotechnologies, FMBA of Russia
Russian Federation

117997; 1, Ostrovityanova St., Build. 10; Moscow
Competing Interests:

There are no conflicts of interest. The authors are solely responsible for submitting the final version of the manuscript for publication. All the authors have participated in developing the concept of the article and in writing the manuscript. The final version of the manuscript has been approved by all the authors



N. E. Ermachenko
Krasnodar Regional Clinical Emergency Hospital
Russian Federation

350042; 14, 40-Letiya Pobedy St.; Krasnodar
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V. A. Kutsenko
National Medical Research Center for Therapy and Preventive Medicine, Ministry of Health of Russia
Russian Federation

101000; 10, Petroverigsky Lane; Moscow
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O. E. Ivlev
M.V. Lomonosov Moscow State University; National Medical Research Center for Therapy and Preventive Medicine, Ministry of Health of Russia
Russian Federation

119991; 1, Leninskie Gory; 101000; 10, Petroverigsky Lane; Moscow
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A. G. Soplenkova
M.V. Lomonosov Moscow State University; National Medical Research Center for Therapy and Preventive Medicine, Ministry of Health of Russia
Russian Federation

119991; 1, Leninskie Gory; 101000; 10, Petroverigsky Lane; Moscow
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M. K. Guseva
V.N. Orekhovich Institute of Biomedical Chemistry
Russian Federation

119121; 10, Pogodinskaya St., Build. 8; Moscow
Competing Interests:

There are no conflicts of interest. The authors are solely responsible for submitting the final version of the manuscript for publication. All the authors have participated in developing the concept of the article and in writing the manuscript. The final version of the manuscript has been approved by all the authors



E. A. Karpova
V.N. Orekhovich Institute of Biomedical Chemistry
Russian Federation

119121; 10, Pogodinskaya St., Build. 8; Moscow
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A. M. Semenov
SuperGene LLC
Russian Federation

119270; 6, Luzhnetskaya Nab., Build. 1; Moscow
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M. P. Semenov
SuperGene LLC
Russian Federation

119270; 6, Luzhnetskaya Nab., Build. 1; Moscow
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I. M. Shirshova
SuperGene LLC
Russian Federation

119270; 6, Luzhnetskaya Nab., Build. 1; Moscow
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S. V. Ivanov
V.N. Orekhovich Institute of Biomedical Chemistry; SuperGene LLC
Russian Federation

119121; 10, Pogodinskaya St., Build. 8; 119270; 6, Luzhnetskaya Nab., Build. 1; Moscow
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Yu. A. Romashova
V.N. Orekhovich Institute of Biomedical Chemistry
Russian Federation

119121; 10, Pogodinskaya St., Build. 8; Moscow
Competing Interests:

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V. V. Beregovykh
V.N. Orekhovich Institute of Biomedical Chemistry
Russian Federation

119121; 10, Pogodinskaya St., Build. 8; Moscow
Competing Interests:

There are no conflicts of interest. The authors are solely responsible for submitting the final version of the manuscript for publication. All the authors have participated in developing the concept of the article and in writing the manuscript. The final version of the manuscript has been approved by all the authors



S. S. Markin
V.N. Orekhovich Institute of Biomedical Chemistry; SuperGene LLC
Russian Federation

119121; 10, Pogodinskaya St., Build. 8; 119270; 6, Luzhnetskaya Nab., Build. 1; Moscow
Competing Interests:

There are no conflicts of interest. The authors are solely responsible for submitting the final version of the manuscript for publication. All the authors have participated in developing the concept of the article and in writing the manuscript. The final version of the manuscript has been approved by all the authors



E. I. Gusev
N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia; Federal Center of Brain and Neurotechnologies, FMBA of Russia
Russian Federation

117997; 1, Ostrovityanova St.; 1, Ostrovityanova St., Build. 10; Moscow
Competing Interests:

There are no conflicts of interest. The authors are solely responsible for submitting the final version of the manuscript for publication. All the authors have participated in developing the concept of the article and in writing the manuscript. The final version of the manuscript has been approved by all the authors



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Review

For citations:

Shamalov NA, Martynov MY, Marskaya NA, Khasanova DR, Yarovaya EB, Voznuk IA, Timchenko LV, Alasheev AM, Khalo NV, Bogatyreva MD, Khan DS, Korsunskaya LL, Nesterova VN, Chefranova ZY, Kharitonova TV, Sutormin MV, Furman OE, Kulesh AA, Zhukovskaya NV, Khoroshavina KV, Korobeynikov IV, Androphagina OV, Bulanov AA, Shamalova DN, Ermachenko NE, Kutsenko VA, Ivlev OE, Soplenkova AG, Guseva MK, Karpova EA, Semenov AM, Semenov MP, Shirshova IM, Ivanov SV, Romashova YA, Beregovykh VV, Markin SS, Gusev EI. Fortelyzin in the treatment of minor acute ischemic stroke according to a subanalysis of the observational study FORPI registry. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2026;18(2):45-53. (In Russ.) https://doi.org/10.14412/2074-2711-2026-2-45-53

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