SVT treated with rivaroxaban vs. fondaparinux

Superficial vein thrombosis (SVT) treated with rivaroxaban versus fondaparinux
(2013, ongoing)

Condition

Treatment of superficial vein thrombosis (SVT)

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Objective

To evaluate the efficacy and safety of rivaroxaban versus fondaparinux in the treatment of SVT

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Trial design

Randomized, open-label phase III study
Active treatment: rivaroxaban 10 mg p.o. once daily for 45 (±5) days
Control treatment: fondaparinux 2.5 mg s.c. once daily for 45 (±5) days

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Endpoints

Primary efficacy endpoint: major bleeding and death from any cause after 90 (±10) days
Secondary outcome measures: major bleeding, death from any cause, major VTE, surgery for SVT, clinically relevant non-major, minor and any bleeding after 90 (±10) days

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Trial participants

~506 patients ≥18 years with acute symptomatic supragenual superficial vein thrombosis of the leg and at least one major risk factor for VTE (e.g. age > 65 years, history of DVT/PE/SVT, SVT of a non-varicose vein)

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Reference

ClinicalTrials.gov (NCT01499953)

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