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

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: 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.

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Publication Details

Journal
S S Korsakov Journal of Neurology and Psychiatry
Published
2026-04-15
DOI
https://doi.org/10.17116/jnevro2026126031106
Citations
2
Primary Topic
Acute Ischemic Stroke Management
Type
article
Field-Weighted Citation Impact
42.42
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article

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

Elena M. Karpova, М.Н. Гусева, Anna G. Soplenkova, Yulia A. Romashova et al.
2 citations
S S Korsakov Journal of Neurology and Psychiatry
Acute Ischemic Stroke Management
42.42
article

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

Elena M. Karpova, М.Н. Гусева, Anna G. Soplenkova, Yulia A. Romashova, А. М. Семенов, I.A. Voznyuk, Д. Р. Хасанова, N. А. Shamalov, А. А. Кулеш, Oleg Ivlev, Ksenia V Choroshavina, Vladimir Aleksandrovich Kutsenko, С. С. Маркин, V. N. Nesterova, Е. B. Yarovaya, В. В. Береговых, O V Androfagina, T. V. Kharitonova, Л. В. Тимченко, A. A. Bulanov, Natalya V. Khalo, Natalya V Zhukovskaya, M. V. Sutormin, Е И Гусев, Zhanna Chefranova, M. V. Bogatyreva, I.V. Korobeynikov, D N Shamalova, N.E. Ermachenko, O.E. Furman, M.Yu. Martynov, A.M. Alasheev, N.A. Marskaya, S.V. Ivanov, L.L. Korsunskaya, I.M. Shirshova, M.P. Semenov, D. S. Khan
article en
2 citations

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: 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.

S S Korsakov Journal of Neurology and PsychiatryVol. 126(3)
Belgorod National Research University (RU), Kazan State Medical University (RU), Lomonosov Moscow State University (RU), First Pavlov State Medical University of St. Petersburg (RU), Pirogov Russian National Research Medical University (RU), Perm State Medical Academy (RU), Stavropol Regional Clinical Oncology Center (RU), Nizhny Novgorod Regional Clinical Hospital named after Semashko (RU), Leningrad Regional Cancer Center (RU), Tver State Medical University (RU), Clinical Hospital No. 8 (RU), Irkutsk Regional Clinical Hospital (RU), Krasnoyarsk Regional Clinical Hospital (RU), Saint-Petersburg I. I. Dzhanelidze Research Institute of Emergency Medicine (RU), City Clinical Hospital (RU), City Clinical Hospital No. 2 (RU), Regional Clinical Research (US), Regional Children's Clinical Hospital No. 1 (RU), Regional Children's Hospital No1 (RU), SuperGen (United States) (US), Moscow State University (TJ), Samara Regional Clinical Hospital named after V.D. Seredavina (RU), Institute of Biomedical Chemistry (RU)
Good health and well-being
Openalex Percentile: Top 0%
Acute Ischemic Stroke Management
42.42
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