Why the study?
The study was designed to compare the efficacy and safety of original rivaroxaban and its generic formulation in patients with stable coronary artery disease.
Does generic rivaroxaban have comparable efficacy and safety to original rivaroxaban when added to ASA in patients with stable CAD?
Does generic rivaroxaban have comparable efficacy and safety to original rivaroxaban when added to ASA in patients with stable CAD?
Answers are grounded in this paper and cite their sources.
This article outlines the design of a prospective study comparing the efficacy and safety of generic versus original rivaroxaban in patients with stable coronary artery disease.
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.
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Lomakin et al. (2025) studied stable coronary artery disease. Generic rivaroxaban (Kruoksaban) vs. Original rivaroxaban (Xarelto) was evaluated on efficacy and safety. This article describes the design of a prospective single-center study comparing the efficacy and safety of original and generic low-dose rivaroxaban in patients with stable coronary artery disease.
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