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Shamalov N.A.

Federal Center for Brain and Neurotechnology, Moscow, Russia;
Pirogov Russian National Research Medical University, Moscow, Russia

Martynov M.Yu.

Federal Center for Brain and Neurotechnology, Moscow, Russia;
Pirogov Russian National Research Medical University, Moscow, Russia

Marskaya N.A.

Federal Center for Brain and Neurotechnology, Moscow, Russia

Khasanova D.R.

Kazan State Medical University, Kazan, Russia

Yarovaya E.B.

Lomonosov Moscow State University, Moscow, Russia

Voznuk I.A.

Academian I.P. Pavlov First State Medical University, St. Petersburg, Russia

Timchenko L.V.

S.V. Ochapovsky Research Institute — Regional Clinical Hospital No. 1, Krasnodar, Russia

Alasheev A.M.

Sverdlovsk Regional Clinical Hospital No. 1, Yekaterinburg, Russia

Khalo N.V.

I.S. Berzon Krasnoyarsk Interdistrict Clinical Hospital No. 20, Krasnoyarsk, Russia

Bogatyreva M.D.

Stavropol Regional Clinical Hospital, Stavropol, Russia

Khan D.S.

Primorsky Regional Clinical Hospital No. 1, Vladivostok, Russia

Korsunskaya L.L.

Simferopol City Clinical Hospital No. 7, Simferopol, Russia

Nesterova V.N.

N.A. Semashko Nizhny Novgorod Regional Clinical Hospital, Nizhny Novgorod, Russia

Chefranova Zh.Yu.

Belgorod State National Research University, Belgorod, Russia

Kharitonova T.V.

I.I. Dzhanelidze Research Institute of Emergency Care, St. Petersburg, Russia

Sutormin M.V.

M.F. Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia

Furman O.E.

M.F. Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia

Kulesh A.A.

E.A. Wagner Perm State Medical University, Perm, Russia;
City Clinical Hospital No. 4, Perm, Russia

Zhukovskaya N.V.

Leningrad Regional Clinical Hospital, St. Petersburg, Russia

Khoroshavina K.V.

Tver Regional Clinical Hospital, Tver, Russia

Korobeynikov I.V.

Irkutsk Regional Clinical Hospital, Irkutsk, Russia

Androphagina O.V.

V.D. Seredavin Samara Regional Clinical Hospital, Samara, Russia

Bulanov A.A.

N.N. Burdenko Penza Regional Clinical Hospital, Penza, Russia

Shamalova D.N.

Pirogov Russian National Research Medical University, Moscow, Russia

Ermachenko N.E.

Krasnodar Regional Clinical Emergency Hospital, Krasnodar, Russia

Kutsenko V.A.

National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russia

Ivlev O.E.

Lomonosov Moscow State University, Moscow, Russia;
National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russia

Soplenkova A.G.

Lomonosov Moscow State University, Moscow, Russia;
National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russia

Guseva M.K.

Institute of Biomedical Chemistry, Moscow, Russia

Karpova E.A.

Institute of Biomedical Chemistry, Moscow, Russia

Semenov A.M.

SuperGene LLC, Moscow, Russia

Semenov M.P.

SuperGene LLC, Moscow, Russia

Shirshova I.M.

SuperGene LLC, Moscow, Russia

Ivanov S.V.

Institute of Biomedical Chemistry, Moscow, Russia;
SuperGene LLC, Moscow, Russia

Romashova Yu.A.

Institute of Biomedical Chemistry, Moscow, Russia

Beregovykh V.V.

Institute of Biomedical Chemistry, Moscow, Russia

Markin S.S.

Institute of Biomedical Chemistry, Moscow, Russia;
SuperGene LLC, Moscow, Russia

Gusev E.I.

Federal Center for Brain and Neurotechnology, Moscow, Russia;
Pirogov Russian National Research Medical University, Moscow, Russia

Fortelyzin in the treatment of acute ischemic stroke in patients ≥80 years old: data from the observational study FORPI registry

Authors:

Shamalov N.A., Martynov M.Yu., Marskaya N.A., Khasanova D.R., Yarovaya E.B., Voznuk I.A., Timchenko L.V., Alasheev A.M., Khalo N.V., Bogatyreva M.D., Khan D.S., Korsunskaya L.L., Nesterova V.N., Chefranova Zh.Yu., Kharitonova T.V., Sutormin M.V., Furman O.E., Kulesh A.A., Zhukovskaya N.V., Khoroshavina K.V., Korobeynikov I.V., Androphagina O.V., Bulanov A.A., Shamalova D.N., Ermachenko N.E., Kutsenko V.A., Ivlev O.E., Soplenkova A.G., Guseva M.K., Karpova E.A., Semenov A.M., Semenov M.P., Shirshova I.M., Ivanov S.V., Romashova Yu.A., Beregovykh V.V., Markin S.S., Gusev E.I.

More about the authors

Journal: S.S. Korsakov Journal of Neurology and Psychiatry. 2026;126(3): 106‑115

DOI: 10.17116/jnevro2026126031106

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Table of contents

FORTELYZIN IN THE TREATMENT OF ACUTE ISCHEMIC STROKE IN PATIENTS ≥80 YEARS OLD: DATA FROM THE OBSERVATIONAL STUDY FORPI REGISTRY
FORTELYZIN IN THE TREATMENT OF ACUTE ISCHEMIC STROKE IN PATIENTS ≥80 YEARS OLD: DATA FROM THE OBSERVATIONAL STUDY FORPI REGISTRY

To cite this article:

Shamalov NA, Martynov MYu, Marskaya NA, et al. Fortelyzin in the treatment of acute ischemic stroke in patients ≥80 years old: data from the observational study FORPI registry. S.S. Korsakov Journal of Neurology and Psychiatry. 2026;126(3):106‑115. (In Russ.)
https://doi.org/10.17116/jnevro2026126031106

Подписка 2026 Журнал неврологии и психиатрии им. С.С. Корсакова (S.S. Korsakov Journal of Neurology and Psychiatry)
МСФ на ЯМ
Использование инфографики авторами научных работ
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Abstract:

OBJECTIVE

The aim of this study was to evaluate the safety and efficacy of Fortelyzin in patients ≥80 years with ischemic stroke (IS) in real-world clinical practice using data from the FORPI registry.

MATERIAL AND METHODS

Fortelyzin (INN/chemical name — a recombinant protein containing the amino acid sequence of staphylokinase, SuperGene LLC, Moscow, Russia) is a thrombolytic used for acute IS treatment within the first 4.5 hours of symptom onset. The FORPI registry is an open-label, prospective, non-interventional, observational study of Fortelyzin in patients with IS. We analyzed the safety and efficacy outcomes in patients ≥80 years compared with patients <80 years. Safety outcomes included the incidence of symptomatic intracranial hemorrhage (sICH) according to ECASS III and SITS-MOST definitions, as well as all-cause mortality on day 90. The efficacy outcome was a good functional recovery, defined by an mRS score of 0—2 on day 90.

RESULTS

2649 (15%) patients were ≥80 years, and 14 987 (85%) patients were <80 years. The median age in the group of patients ≥80 years was 83 (82—86) years. Patients ≥80 years were characterized by a more complicated medical history and a higher median of NIHSS and mRS score. The sICH rate according to ECASS III definition in patients ≥80 years old was 4.0%, in patients <80 years old — 1.7% (OR 2.42 (1.90—3.07), p<0.001), according to SITS-MOST definition — 3.2% and 1.6%, respectively (OR 2.03 (1.56—2.61), p<0.001); in-hospital all-cause mortality was 17% and 7% (OR 2.76 (2.44—3.11, p<0.001), all-cause mortality on day 90 was 19% and 7% (OR 3.00 (2.67—3.37, p<0.001), respectively. Good functional recovery (mRS 0—2 score) on day 90 was achieved in 43% of patients ≥80 years and 64% in patients <80 years of age (OR 0.42 (0.38—0.46, p<0.001)).

CONCLUSION

FORPI study showed that although the risk of sICH with Fortelyzin is higher in patients ≥80 years than in patients <80 years, it remains low, suggesting that thrombolytic therapy is safe and necessary in these patients.

Keywords:

acute ischemic stroke
intravenous thrombolysis
elderly patients
Fortelyzin

Authors:

Shamalov N.A.

Federal Center for Brain and Neurotechnology, Moscow, Russia;
Pirogov Russian National Research Medical University, Moscow, Russia

Martynov M.Yu.

Federal Center for Brain and Neurotechnology, Moscow, Russia;
Pirogov Russian National Research Medical University, Moscow, Russia

Marskaya N.A.

Federal Center for Brain and Neurotechnology, Moscow, Russia

Khasanova D.R.

Kazan State Medical University, Kazan, Russia

Yarovaya E.B.

Lomonosov Moscow State University, Moscow, Russia

Voznuk I.A.

Academian I.P. Pavlov First State Medical University, St. Petersburg, Russia

Timchenko L.V.

S.V. Ochapovsky Research Institute — Regional Clinical Hospital No. 1, Krasnodar, Russia

Alasheev A.M.

Sverdlovsk Regional Clinical Hospital No. 1, Yekaterinburg, Russia

Khalo N.V.

I.S. Berzon Krasnoyarsk Interdistrict Clinical Hospital No. 20, Krasnoyarsk, Russia

Bogatyreva M.D.

Stavropol Regional Clinical Hospital, Stavropol, Russia

Khan D.S.

Primorsky Regional Clinical Hospital No. 1, Vladivostok, Russia

Korsunskaya L.L.

Simferopol City Clinical Hospital No. 7, Simferopol, Russia

Nesterova V.N.

N.A. Semashko Nizhny Novgorod Regional Clinical Hospital, Nizhny Novgorod, Russia

Chefranova Zh.Yu.

Belgorod State National Research University, Belgorod, Russia

Kharitonova T.V.

I.I. Dzhanelidze Research Institute of Emergency Care, St. Petersburg, Russia

Sutormin M.V.

M.F. Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia

Furman O.E.

M.F. Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia

Kulesh A.A.

E.A. Wagner Perm State Medical University, Perm, Russia;
City Clinical Hospital No. 4, Perm, Russia

Zhukovskaya N.V.

Leningrad Regional Clinical Hospital, St. Petersburg, Russia

Khoroshavina K.V.

Tver Regional Clinical Hospital, Tver, Russia

Korobeynikov I.V.

Irkutsk Regional Clinical Hospital, Irkutsk, Russia

Androphagina O.V.

V.D. Seredavin Samara Regional Clinical Hospital, Samara, Russia

Bulanov A.A.

N.N. Burdenko Penza Regional Clinical Hospital, Penza, Russia

Shamalova D.N.

Pirogov Russian National Research Medical University, Moscow, Russia

Ermachenko N.E.

Krasnodar Regional Clinical Emergency Hospital, Krasnodar, Russia

Kutsenko V.A.

National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russia

Ivlev O.E.

Lomonosov Moscow State University, Moscow, Russia;
National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russia

Soplenkova A.G.

Lomonosov Moscow State University, Moscow, Russia;
National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russia

Guseva M.K.

Institute of Biomedical Chemistry, Moscow, Russia

Karpova E.A.

Institute of Biomedical Chemistry, Moscow, Russia

Semenov A.M.

SuperGene LLC, Moscow, Russia

Semenov M.P.

SuperGene LLC, Moscow, Russia

Shirshova I.M.

SuperGene LLC, Moscow, Russia

Ivanov S.V.

Institute of Biomedical Chemistry, Moscow, Russia;
SuperGene LLC, Moscow, Russia

Romashova Yu.A.

Institute of Biomedical Chemistry, Moscow, Russia

Beregovykh V.V.

Institute of Biomedical Chemistry, Moscow, Russia

Markin S.S.

Institute of Biomedical Chemistry, Moscow, Russia;
SuperGene LLC, Moscow, Russia

Gusev E.I.

Federal Center for Brain and Neurotechnology, Moscow, Russia;
Pirogov Russian National Research Medical University, Moscow, Russia

Received:

16.01.2026

Accepted:

19.01.2026

Close metadata

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