Protocol of a Prospective Cohort Study of Generic Rivaroxaban for Lower Extremity Deep Vein Thrombosis During Initial and Long-Term Anticoagulation: a Comparison with a Historical Control Group Receiving Original Rivaroxaban

The advent of generic drugs enhances the availability of antithrombotic therapy. Widespread use of generics requires preliminary analysis of their clinical efficacy and safety compared to the reference drug. Objective. To perform an exploratory evaluation of the therapeutic sufficiency, clinical effectiveness and safety of generic rivaroxaban versus the reference drug in the treatment of patients with lower extremity deep vein thrombosis (DVT) during the initial and long-term anticoagulation in a real-world clinical setting. Material and methods. An exploratory observational study with a historical control group is planned, utilizing data from the COBRRA project as the control. The study is designed in accordance with the STROBE standards for observational studies and is registered in the Clinical Trials Registry of the Russian Phlebological Association (ID: VTE.036.07.04022026). The primary outcome is the relative incidence of clinically relevant bleeding, defined as major bleeding (MB) or clinically relevant non-major bleeding (CRNMB). Secondary outcomes: relative incidence rates of the composite endpoint (combined progression of thrombosis, MB, and CRNMB); of thrombosis progression; of MB; of CRNMB; absolute rates of VTE-related, bleeding-related and all-cause mortality; patient compliance categories.