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Comparative clinical and laboratory study of rivaroxaban and its generic forms in patients with stable coronary artery disease

https://doi.org/10.15829/1560-4071-2025-6286

EDN: TEWITO

Abstract

The course and complications of coronary artery disease (CAD) are associated with atherosclerosis progression and a high probability of atherothrombosis. Antithrombotic therapy is the most effective strategy for preventing cardiovascular events in atherosclerotic diseases. In accordance with current clinical guidelines for the prevention of myocardial infarction and stroke, all patients with stable CAD are recommended to take acetylsalicylic acid (ASA). In patients with a high risk of ischemic events without a high risk of bleeding, addition of low dose anticoagulant rivaroxaban to ASA is possible. The article discusses the design of a clinical and laboratory prospective single-center comparative study, the purpose of which is to compare the efficacy and safety of two following bioequivalent agents: the original (Xarelto, AO Bayer, Germany) and generic (Kruoksaban, OOO Ozon LLC, Russia) rivaroxaban.

About the Authors

N. V. Lomakin
Central Clinical Hospital with a Polyclinic of the Administrative Directorate of the President of the Russian Federation; Russian Medical Academy of Continuous Professional Education
Russian Federation

Moscow


Competing Interests:

none



I. Yu. Tkach
Central Clinical Hospital with a Polyclinic of the Administrative Directorate of the President of the Russian Federation; Russian Medical Academy of Continuous Professional Education
Russian Federation

Moscow


Competing Interests:

none



E. A. Shirokov
Russian Medical Academy of Continuous Professional Education
Russian Federation

Moscow


Competing Interests:

none



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  • All patients with stable coronary artery disease and a high risk of ischemic events without a high risk of bleeding are recommended to consider adding a second antiplatelet agent or the anticoagulant rivaroxaban at a dose of 2,5 mg 2 times a day to acetylsalicylic acid.
  • Laboratory effects reflecting the hemostasis status and pharmacodynamics of the original rivaroxaban (Xarelto, AO Bayer, Germany) at a dose of 2,5 mg 2 times a day and generic rivaroxaban (Kruoksaban, Ozon LLC, Russia) will be studied.

Review

For citations:


Lomakin N.V., Tkach I.Yu., Shirokov E.A. Comparative clinical and laboratory study of rivaroxaban and its generic forms in patients with stable coronary artery disease. Russian Journal of Cardiology. 2025;30(2):6286. (In Russ.) https://doi.org/10.15829/1560-4071-2025-6286. EDN: TEWITO

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ISSN 1560-4071 (Print)
ISSN 2618-7620 (Online)