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.
Authors
- Elena M. Karpova (ORCID: https://orcid.org/0000-0003-1291-3838)
- М.Н. Гусева (ORCID: https://orcid.org/0000-0002-5576-6164)
- Anna G. Soplenkova (ORCID: https://orcid.org/0000-0003-0703-146X)
- Yulia A. Romashova (ORCID: https://orcid.org/0000-0001-9580-0251)
- А. М. Семенов (ORCID: https://orcid.org/0000-0003-1247-4978)
- I.A. Voznyuk (ORCID: https://orcid.org/0000-0002-4292-4258)
- Д. Р. Хасанова (ORCID: https://orcid.org/0000-0002-8825-2346)
- N. А. Shamalov (ORCID: https://orcid.org/0000-0001-6250-0762)
- А. А. Кулеш (ORCID: https://orcid.org/0000-0001-6061-8118)
- Oleg Ivlev (ORCID: https://orcid.org/0000-0002-3663-6305)
- Ksenia V Choroshavina (ORCID: https://orcid.org/0000-0001-7165-6793)
- Vladimir Aleksandrovich Kutsenko (ORCID: https://orcid.org/0000-0001-9844-3122)
- С. С. Маркин (ORCID: https://orcid.org/0000-0002-0242-0282)
- V. N. Nesterova
- Е. B. Yarovaya (ORCID: https://orcid.org/0000-0002-6615-4315)
- В. В. Береговых (ORCID: https://orcid.org/0000-0002-0210-4570)
- O V Androfagina (ORCID: https://orcid.org/0000-0002-4217-1989)
- T. V. Kharitonova (ORCID: https://orcid.org/0000-0003-4021-9421)
- Л. В. Тимченко (ORCID: https://orcid.org/0000-0001-6341-0101)
- A. A. Bulanov
- Natalya V. Khalo (ORCID: https://orcid.org/0000-0001-5603-6318)
- Natalya V Zhukovskaya (ORCID: https://orcid.org/0000-0002-7434-3044)
- M. V. Sutormin (ORCID: https://orcid.org/0009-0004-8742-6182)
- Е И Гусев
- Zhanna Chefranova (ORCID: https://orcid.org/0000-0002-2106-7461)
- M. V. Bogatyreva (ORCID: https://orcid.org/0000-0002-8838-5958)
- I.V. Korobeynikov
- D N Shamalova
- N.E. Ermachenko
- O.E. Furman
- M.Yu. Martynov (ORCID: https://orcid.org/0000-0003-2797-7877)
- A.M. Alasheev (ORCID: https://orcid.org/0000-0003-1610-2127)
- N.A. Marskaya (ORCID: https://orcid.org/0000-0002-0789-4823)
- S.V. Ivanov (ORCID: https://orcid.org/0000-0003-0438-9108)
- L.L. Korsunskaya (ORCID: https://orcid.org/0000-0003-0958-130X)
- I.M. Shirshova (ORCID: https://orcid.org/0009-0007-3451-1887)
- M.P. Semenov (ORCID: https://orcid.org/0000-0002-6877-4817)
- D. S. Khan (ORCID: https://orcid.org/0000-0002-7179-1917)
Institutions
- 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)
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