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Shamalov N.A.

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

Martynov M.Yu.

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

Gusev E.I.

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

Marskaya N.A.

Federal Center for Brain and Neurotechnology

Khasanova D.R.

Kazan State Medical University

Yarovaya E.B.

Lomonosov Moscow State University

Chefranova Zh.Yu.

Belgorod State National Research University

Voznyuk I.A.

I.P. Pavlov First State Medical University

Alasheev A.M.

Regional Clinical Hospital No. 1

Chuprina S.E.

Regional Clinical Hospital No. 1

Khalo N.V.

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

Bogatyreva M.D.

Stavropol Regional Clinical Hospital

Khan D.S.

Primorsky Regional Clinical Hospital No. 1

Rakhmatullin A.R.

Ministry of Health of the Republic of Bashkortostan

Korsunskaya L.L.

Simferopol City Clinical Hospital No. 7

Kharitonova T.V.

I.I. Dzhanelidze Research Institute of Emergency Care

Sutormin M.V.

Vladimirskii Moscow Regional Research and Clinical Institute

Timchenko L.V.

Research Institute — Ochapovsky Regional Clinic Hospital No.1

Nesterova V.N.

Regional Clinical Hospital

Kulesh A.A.

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

Zhukovskaya N.V.

Leningrad Regional Clinical Hospital

Choroshavina K.V.

Regional Clinical Hospital

Karamova I.M.

Ufa Emergency Hospital

Lebedeva A.Yu.

Moscow Multidisciplinary Clinical Center «Kommunarka»

Korobeynikov I.V.

Regional Clinical Hospital

Androfagina O.V.

Seredavin Samara Regional Clinical Hospital

Kutsenko V.A.

National Medical Research Center for Therapy and Preventive Medicine

Ivlev O.E.

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

Soplenkova A.G.

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

Sazhnev A.I.

V.D. Babenko Tambov Regional Clinical Hospital

Ternovskaya V.A.

Bryansk Regional Hospital No. 1

Teryaeva I.V.

City Clinical Hospital

Schegolev A.Yu.

Lipetsk Regional Clinical Hospital

Maslova N.N.

Smolensk State Medical University

Daynikova E.I.

Clinical Hospital No. 2

Lykov Yu.A.

Belgorod Regional Clinical Hospital of St. Joasaph

Mnev A.A.

Vladimir Regional Clinical Hospital

Kholopov M.A.

«Sosnovaya Roshcha» City Clinical Hospital

Batueva Yu.V.

Ivanovo Regional Clinical Hospital

Kirukhina N.N.

Ryazan Regional Clinical Hospital

Birukov A.E.

Kursk Regional Multidisciplinary Clinical Hospital

Abramceva V.V.

Oryol Regional Clinical Hospital

Tabakman S.V.

Pirogov City Hospital No. 1

Kladova I.V.

Rostov Regional Clinical Hospital

Mamina R.M.

City Polyclinic No. 5

Shatunova A.V.

S.Z. Fisher City Clinical Hospital No. 1

Vakazheva S.A.

Adyghe Republican Clinical Hospital

Bukaeva A.N.

P.P. Zhemchuev Kalmykia Republican Hospital

Karasev A.A.

Mordovian Republican Central Clinical Hospital

Chirkov A.N.

Orenburg Regional Clinical Hospital named after V.I. Voinov

Philippov P.G.

G.A. Zakharyin Clinical Hospital No. 6

Slasten E.V.

V.A. Egorov Central Clinical Medical-Sanitary Unit

Kurnosov S.I.

Saratov Regional Clinical Hospital

Komissarova N.V.

First Republican Clinical Hospital of the Ministry of Health of the Udmurt Republic

Shishkina E.N.

City Hospital

Maltsev V.G.

Cardiology and Neurology Center

Ivanova V.V.

Republican Clinical Hospital of the Ministry of Health of Chuvashia

Volkova A.K.

Central Clinical Hospital

Golubeva E.A.

City Clinical Hospital No. 11

Bort A.A.

Omsk Regional Clinical Hospital

Gaponenko I.A.

Clinical Cardiology Dispensary

Fedyanin S.A.

Altai Regional Clinical Hospital

Alifirova V.M.

Siberian State Medical University

Farenbrukh S.V.

G.Ya. Remishevskaya Republican Clinical Hospital

Mongush Kh.D.

Republican Hospital No. 1, Kyzyl

Tikhomirova O.V.

A.M. Nikiforov All-Russian Center for Emergency and Radiation Medicine

Azarova A.G.

Pskov Regional Clinical Hospital

Andreyko N.V.

Vologda Regional Clinical Hospital No. 2

Stepushenkova D.L.

Kaliningrad Regional Clinical Hospital

Cherepyansky M.S.

Komi Republican Clinical Hospital

Maximov V.I.

V.A. Baranov Republican Hospital

Saskin V.A.

E.E. Volosevich Arkhangelsk Region First City Clinical Hospital

Timofeev A.A.

P.A. Bayandin Murmansk Regional Clinical Hospital

Kuzmin E.L.

Novgorod Regional Clinical Hospital

Brutyan G.S.

Tyumen Regional Clinical Hospital No. 2

Evdokimova V.A.

Kurgan Emergency Hospital

Zinoveva N.P.

City Clinical Hospital No. 1

Ulimbasheva E.S.

Republican Clinical Hospital of the Ministry of Health of the Kabardino-Balkarian Republic

Gasambekova S.N.

Dagestan Republican Clinical Hospital

Dzugaeva F.K.

North Caucasus Multidisciplinary Medical Center

Batukaeva L.A.

A.A. Kadyrov Chechen Republican Clinical Hospital

Tekeev M.B.

Karachay-Cherkessia Multidisciplinary Medical Center

Balaeva M.Kh.

Sunzhenskaya Central District Hospital

Lisin S.A.

Amur Regional Clinical Hospital

Sharina S.F.

Sakha (Yakutia) Republican Hospital No. 2 — Emergency Medical Care Center

Terentyeva A.E.

A.S. Lukashevsky Kamchatka Regional Hospital

Uskova N.I.

Zabaikalsky Regional Clinical Hospital

Strambovskaya N.N.

N.A. Semashko Republican Clinical Hospital

Shamin A.A.

Magadan Regional Hospital

Guseva M.K.

Institute of Biomedical Chemistry

Karpova E.A.

Institute of Biomedical Chemistry

Semenov A.M.

SuperGene LLC

Ivanov S.V.

Institute of Biomedical Chemistry;
SuperGene LLC

Semenov M.P.

SuperGene LLC

Romashova Yu.A.

Institute of Biomedical Chemistry

Beregovykh V.V.

Institute of Biomedical Chemistry

Markin S.S.

Institute of Biomedical Chemistry;
SuperGene LLC

Fortelyzin for acute ischaemic stroke treatment: an open, prospective, non-interventional, observational study FORPI registry

Authors:

Shamalov N.A., Martynov M.Yu., Gusev E.I., Marskaya N.A., Khasanova D.R., Yarovaya E.B., Chefranova Zh.Yu., Voznyuk I.A., Alasheev A.M., Chuprina S.E., Khalo N.V., Bogatyreva M.D., Khan D.S., Rakhmatullin A.R., Korsunskaya L.L., Kharitonova T.V., Sutormin M.V., Timchenko L.V., Nesterova V.N., Kulesh A.A., Zhukovskaya N.V., Choroshavina K.V., Karamova I.M., Lebedeva A.Yu., Korobeynikov I.V., Androfagina O.V., Kutsenko V.A., Ivlev O.E., Soplenkova A.G., Sazhnev A.I., Ternovskaya V.A., Teryaeva I.V., Schegolev A.Yu., Maslova N.N., Daynikova E.I., Lykov Yu.A., Mnev A.A., Kholopov M.A., Batueva Yu.V., Kirukhina N.N., Birukov A.E., Abramceva V.V., Tabakman S.V., Kladova I.V., Mamina R.M., Shatunova A.V., Vakazheva S.A., Bukaeva A.N., Karasev A.A., Chirkov A.N., Philippov P.G., Slasten E.V., Kurnosov S.I., Komissarova N.V., Shishkina E.N., Maltsev V.G., Ivanova V.V., Volkova A.K., Golubeva E.A., Bort A.A., Gaponenko I.A., Fedyanin S.A., Alifirova V.M., Farenbrukh S.V., Mongush Kh.D., Tikhomirova O.V., Azarova A.G., Andreyko N.V., Stepushenkova D.L., Cherepyansky M.S., Maximov V.I., Saskin V.A., Timofeev A.A., Kuzmin E.L., Brutyan G.S., Evdokimova V.A., Zinoveva N.P., Ulimbasheva E.S., Gasambekova S.N., Dzugaeva F.K., Batukaeva L.A., Tekeev M.B., Balaeva M.Kh., Lisin S.A., Sharina S.F., Terentyeva A.E., Uskova N.I., Strambovskaya N.N., Shamin A.A., Guseva M.K., Karpova E.A., Semenov A.M., Ivanov S.V., Semenov M.P., Romashova Yu.A., Beregovykh V.V., Markin S.S.

More about the authors

Journal: S.S. Korsakov Journal of Neurology and Psychiatry. 2025;125(12): 43‑59

DOI: 10.17116/jnevro202512512143

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Table of contents

FORTELYZIN FOR ACUTE ISCHAEMIC STROKE TREATMENT: AN OPEN, PROSPECTIVE, NON-INTERVENTIONAL, OBSERVATIONAL STUDY FORPI REGISTRY
FORTELYZIN FOR ACUTE ISCHAEMIC STROKE TREATMENT: AN OPEN, PROSPECTIVE, NON-INTERVENTIONAL, OBSERVATIONAL STUDY FORPI REGISTRY

To cite this article:

Shamalov NA, Martynov MYu, Gusev EI, et al. . Fortelyzin for acute ischaemic stroke treatment: an open, prospective, non-interventional, observational study FORPI registry. S.S. Korsakov Journal of Neurology and Psychiatry. 2025;125(12):43‑59. (In Russ.)
https://doi.org/10.17116/jnevro202512512143

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

To evaluate safety and efficacy outcomes of Fortelyzin in AIS patients in the FORPI (Fortelyzin Population Investigation) registry.

MATERIAL AND METHODS

Between March 2021 and October 2024 AIS patients treated with Fortelyzin were enrolled in prospective, open, monitored, observational FORPI registry. Demographics, risk factors, baseline stroke severity, defined by National Institutes of Health Stroke Scale (NIHSS), and onset to treatment time were recorded. Safety outcomes included symptomatic intracerebral haemorrhage (ICH) (according to the ECASS III and SITS-MOST criteria) within 36 h and all-cause mortality on day 90. Efficacy outcome was evaluated as a functional independence defined by modified Rankin scale (mRS score of 0—2) on day 90.

RESULTS

A total of 17 636 AIS patients were treated with Fortelyzin in 329 centres participated in the FORPI registry during the study period (median age 68 [60; 75]; 44% women; median baseline NIHSS score: 11 [8;16] points; median onset to treatment time: 2.4 [1.8; 3.1] h. 73% of patients (12947/17 636) received thrombolytic therapy in the first three hours from symptoms onset. The rate of symptomatic ICH according to the ECASS III criteria was 2% [1.8; 2.2] (356/17636), to the SITS-MOST criteria — 2% [1.8; 2.1] (330/17 636). All-cause mortality on day 90 was 9% [8.6; 9.4] (1588/17 636). The number of patients with mRS 0—2 score on day 90 was 61% [60.5; 61.9] (10799/17636). All safety and efficacy outcomes were comparable with FRIDA randomised clinical trial results.

CONCLUSION

The presented data confirm that intravenous thrombolysis with Fortelyzin is safe and effective in routine clinical practice when used within 4.5 h of AIS symptoms onset. These findings should encourage the wider usage of thrombolytic therapy for suitable patients.

Keywords:

acute ischemic stroke
intravenous thrombolysis
Fortelyzin
non-immunogenic staphylokinase

Authors:

Shamalov N.A.

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

Martynov M.Yu.

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

Gusev E.I.

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

Marskaya N.A.

Federal Center for Brain and Neurotechnology

Khasanova D.R.

Kazan State Medical University

Yarovaya E.B.

Lomonosov Moscow State University

Chefranova Zh.Yu.

Belgorod State National Research University

Voznyuk I.A.

I.P. Pavlov First State Medical University

Alasheev A.M.

Regional Clinical Hospital No. 1

Chuprina S.E.

Regional Clinical Hospital No. 1

Khalo N.V.

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

Bogatyreva M.D.

Stavropol Regional Clinical Hospital

Khan D.S.

Primorsky Regional Clinical Hospital No. 1

Rakhmatullin A.R.

Ministry of Health of the Republic of Bashkortostan

Korsunskaya L.L.

Simferopol City Clinical Hospital No. 7

Kharitonova T.V.

I.I. Dzhanelidze Research Institute of Emergency Care

Sutormin M.V.

Vladimirskii Moscow Regional Research and Clinical Institute

Timchenko L.V.

Research Institute — Ochapovsky Regional Clinic Hospital No.1

Nesterova V.N.

Regional Clinical Hospital

Kulesh A.A.

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

Zhukovskaya N.V.

Leningrad Regional Clinical Hospital

Choroshavina K.V.

Regional Clinical Hospital

Karamova I.M.

Ufa Emergency Hospital

Lebedeva A.Yu.

Moscow Multidisciplinary Clinical Center «Kommunarka»

Korobeynikov I.V.

Regional Clinical Hospital

Androfagina O.V.

Seredavin Samara Regional Clinical Hospital

Kutsenko V.A.

National Medical Research Center for Therapy and Preventive Medicine

Ivlev O.E.

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

Soplenkova A.G.

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

Sazhnev A.I.

V.D. Babenko Tambov Regional Clinical Hospital

Ternovskaya V.A.

Bryansk Regional Hospital No. 1

Teryaeva I.V.

City Clinical Hospital

Schegolev A.Yu.

Lipetsk Regional Clinical Hospital

Maslova N.N.

Smolensk State Medical University

Daynikova E.I.

Clinical Hospital No. 2

Lykov Yu.A.

Belgorod Regional Clinical Hospital of St. Joasaph

Mnev A.A.

Vladimir Regional Clinical Hospital

Kholopov M.A.

«Sosnovaya Roshcha» City Clinical Hospital

Batueva Yu.V.

Ivanovo Regional Clinical Hospital

Kirukhina N.N.

Ryazan Regional Clinical Hospital

Birukov A.E.

Kursk Regional Multidisciplinary Clinical Hospital

Abramceva V.V.

Oryol Regional Clinical Hospital

Tabakman S.V.

Pirogov City Hospital No. 1

Kladova I.V.

Rostov Regional Clinical Hospital

Mamina R.M.

City Polyclinic No. 5

Shatunova A.V.

S.Z. Fisher City Clinical Hospital No. 1

Vakazheva S.A.

Adyghe Republican Clinical Hospital

Bukaeva A.N.

P.P. Zhemchuev Kalmykia Republican Hospital

Karasev A.A.

Mordovian Republican Central Clinical Hospital

Chirkov A.N.

Orenburg Regional Clinical Hospital named after V.I. Voinov

Philippov P.G.

G.A. Zakharyin Clinical Hospital No. 6

Slasten E.V.

V.A. Egorov Central Clinical Medical-Sanitary Unit

Kurnosov S.I.

Saratov Regional Clinical Hospital

Komissarova N.V.

First Republican Clinical Hospital of the Ministry of Health of the Udmurt Republic

Shishkina E.N.

City Hospital

Maltsev V.G.

Cardiology and Neurology Center

Ivanova V.V.

Republican Clinical Hospital of the Ministry of Health of Chuvashia

Volkova A.K.

Central Clinical Hospital

Golubeva E.A.

City Clinical Hospital No. 11

Bort A.A.

Omsk Regional Clinical Hospital

Gaponenko I.A.

Clinical Cardiology Dispensary

Fedyanin S.A.

Altai Regional Clinical Hospital

Alifirova V.M.

Siberian State Medical University

Farenbrukh S.V.

G.Ya. Remishevskaya Republican Clinical Hospital

Mongush Kh.D.

Republican Hospital No. 1, Kyzyl

Tikhomirova O.V.

A.M. Nikiforov All-Russian Center for Emergency and Radiation Medicine

Azarova A.G.

Pskov Regional Clinical Hospital

Andreyko N.V.

Vologda Regional Clinical Hospital No. 2

Stepushenkova D.L.

Kaliningrad Regional Clinical Hospital

Cherepyansky M.S.

Komi Republican Clinical Hospital

Maximov V.I.

V.A. Baranov Republican Hospital

Saskin V.A.

E.E. Volosevich Arkhangelsk Region First City Clinical Hospital

Timofeev A.A.

P.A. Bayandin Murmansk Regional Clinical Hospital

Kuzmin E.L.

Novgorod Regional Clinical Hospital

Brutyan G.S.

Tyumen Regional Clinical Hospital No. 2

Evdokimova V.A.

Kurgan Emergency Hospital

Zinoveva N.P.

City Clinical Hospital No. 1

Ulimbasheva E.S.

Republican Clinical Hospital of the Ministry of Health of the Kabardino-Balkarian Republic

Gasambekova S.N.

Dagestan Republican Clinical Hospital

Dzugaeva F.K.

North Caucasus Multidisciplinary Medical Center

Batukaeva L.A.

A.A. Kadyrov Chechen Republican Clinical Hospital

Tekeev M.B.

Karachay-Cherkessia Multidisciplinary Medical Center

Balaeva M.Kh.

Sunzhenskaya Central District Hospital

Lisin S.A.

Amur Regional Clinical Hospital

Sharina S.F.

Sakha (Yakutia) Republican Hospital No. 2 — Emergency Medical Care Center

Terentyeva A.E.

A.S. Lukashevsky Kamchatka Regional Hospital

Uskova N.I.

Zabaikalsky Regional Clinical Hospital

Strambovskaya N.N.

N.A. Semashko Republican Clinical Hospital

Shamin A.A.

Magadan Regional Hospital

Guseva M.K.

Institute of Biomedical Chemistry

Karpova E.A.

Institute of Biomedical Chemistry

Semenov A.M.

SuperGene LLC

Ivanov S.V.

Institute of Biomedical Chemistry;
SuperGene LLC

Semenov M.P.

SuperGene LLC

Romashova Yu.A.

Institute of Biomedical Chemistry

Beregovykh V.V.

Institute of Biomedical Chemistry

Markin S.S.

Institute of Biomedical Chemistry;
SuperGene LLC

Received:

14.11.2025

Accepted:

12.12.2025

Close metadata

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