Non-Immunogenic Staphylokinase vs Alteplase in Patients with Massive Pulmonary Embolism: the Protocol of a Multiple-Center Open-Label Randomized Trial FORPE

Kirienko A.I.; Yarovaya E.B.; Kutsenko V.A.; Orlovsky A.A.; Ivanov S.V.; Semenov M.P.; Semenov A.M.; Leontiev S.G.; Markin S.S.

doi:https://doi.org/10.17116/flebo202216021114

Kirienko A.I.

Pirogov Russian National Research Medical University

SPIN RSCI: 8319-5682
Scopus AuthorID: 7007011716
ResearcherID: AAA-5162-2019
ORCID: 0000-0001-8792-1694

Yarovaya E.B.

Lomonosov Moscow State University

ORCID: 0000-0002-6615-4315

Kutsenko V.A.

National Medical Research Center for Therapy and Preventive Medicine

ORCID: 0000-0001-9844-3122

Orlovsky A.A.

Lomonosov Moscow State University

ORCID: 0000-0002-0794-4683

Ivanov S.V.

Mental Health Research Center

ORCID: 0000-0001-9532-7150

Semenov M.P.

SuperGene LLC

ORCID: 0000-0002-6877-4817

Semenov A.M.

SuperGene LLC

ORCID: 0000-0003-1247-4978

Leontiev S.G.

Research Institute of Clinical Surgery of the Pirogov Russian National Research Medical University

Markin S.S.

SuperGene LLC

ORCID: 0000-0002-0242-0282

Non-Immunogenic Staphylokinase vs Alteplase in Patients with Massive Pulmonary Embolism: the Protocol of a Multiple-Center Open-Label Randomized Trial FORPE

Authors:

Kirienko A.I., Yarovaya E.B., Kutsenko V.A., Orlovsky A.A., Ivanov S.V., Semenov M.P., Semenov A.M., Leontiev S.G., Markin S.S.

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Journal: Journal of Venous Disorders. 2022;16(2): 114‑121

DOI: 10.17116/flebo202216021114

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To cite this article:

Kirienko AI, Yarovaya EB, Kutsenko VA, et al. . Non-Immunogenic Staphylokinase vs Alteplase in Patients with Massive Pulmonary Embolism: the Protocol of a Multiple-Center Open-Label Randomized Trial FORPE. Journal of Venous Disorders. 2022;16(2):114‑121. (In Russ.)
https://doi.org/10.17116/flebo202216021114

Подписка 2026 Флебология (Journal of Venous Disorders)

Использование инфографики авторами научных работ

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OBJECTIVE

To evaluate the efficacy and safety of single bolus of non-immunogenic staphylokinase compared to infusion of alteplase in patients with massive pulmonary embolism.

MATERIAL AND METHODS

Non-immunogenic staphylokinase has a high thrombolytic activity and fibrin selectivity. The FORPE Clinical Trial is a randomized open-label multiple-center parallel-group non-inferiority study. At the clinical sites, patients (n=310 considering possible 10% dropout) with massive pulmonary embolism confirmed by CT pulmonary angiography will be equally randomized into 2 groups for appointment of non-immunogenic staphylokinase or alteplase. The study protocol presents the inclusion and exclusion criteria, analysis of sample size. The primary efficacy endpoint of thrombolytic therapy with non-immunogenic staphylokinase vs alteplase was overall mortality within 7 days. Safety criteria will be ischemic and hemorrhagic stroke within 7 days after thrombolysis and bleeding BARC type 3 and 5.

RESULTS

Data on efficacy and safety of non-immunogenic staphylokinase in patients with massive pulmonary embolism will be obtained. A report with attachments of individual and statistical data will be drawn up. Scientific results will be published and presented at various conferences.

REGISTRATION

The FORPE trial protocol was approved by the Ministry of Health of Russia No. 16 dated January 15, 2019 with additions dated July 5, 2021, the Ethics Council of the Ministry of Health of Russia No. 182 dated December 4, 2018 and registered at clinicaltrials.gov No. NCT04688320 (FORPE).

Keywords:

massive pulmonary embolism

thrombolysis

non-immunogenic staphylokinase

alteplase

Authors:

Kirienko A.I.

Pirogov Russian National Research Medical University

SPIN RSCI: 8319-5682
Scopus AuthorID: 7007011716
ResearcherID: AAA-5162-2019
ORCID: 0000-0001-8792-1694

Yarovaya E.B.

Lomonosov Moscow State University

ORCID: 0000-0002-6615-4315

Kutsenko V.A.

National Medical Research Center for Therapy and Preventive Medicine

ORCID: 0000-0001-9844-3122

Orlovsky A.A.

Lomonosov Moscow State University

ORCID: 0000-0002-0794-4683

Ivanov S.V.

Mental Health Research Center

ORCID: 0000-0001-9532-7150

Semenov M.P.

SuperGene LLC

ORCID: 0000-0002-6877-4817

Semenov A.M.

SuperGene LLC

ORCID: 0000-0003-1247-4978

Leontiev S.G.

Research Institute of Clinical Surgery of the Pirogov Russian National Research Medical University

Markin S.S.

SuperGene LLC

ORCID: 0000-0002-0242-0282

Received:

15.02.2022

Accepted:

18.03.2022

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References:

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