The purpose of this study is to evaluate the efficacy and safety of rivaroxaban versus fondaparinux in the treatment of superficial vein thrombosis (SVT).
Evaluation of efficacy and safety of 45 days of rivaroxaban 10 mg vs. fondaparinux 2.5 mg in the treatment of superficial vein thrombosis of risk patients for major VTE complications to prove non-inferiority of oral rivaroxaban treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
472
Dose: 10 mg Duration: 45 (±5) days Frequency: once daily Application: oral
Fondaparinux Dose: 2.5 mg Duration: 45 (±5) days Frequency: once daily Application: subcutaneous
Hautarztpraxis
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Rate of Objectively Confirmed VTE Complications
The primary efficacy outcome was the composite of death from any cause, symptomatic pulmonary embolism (confirmed by ventilation-perfusion scanning, helical computed tomography, pulmonary angiography, or autopsy), symptomatic deep vein thrombosis (confirmed by ultrasonography or venography), or symptomatic extension towards the saphenofemoral junction or symptomatic recurrence of superficial vein thrombosis (confirmed by ultrasonography) up to day 45.
Time frame: 45 +/- 5 days
Composite Primary Efficacy Outcome
For this, secondary efficacy outcomes were the composite primary efficacy outcome up to Day 90 and the following outcomes up to Day 45 and Day 90: each component of the primary efficacy outcome, the rate of major VTE (composite of symptomatic pulmonary embolism or symptomatic proximal DVT or VTE-related death) and the rates of surgery for SVT.
Time frame: 90 +/- 10 days
Rate of Major VTE
composite of: * symptomatic pulmonary embolism * symptomatic proximal DVT * VTE-related death
Time frame: 90 +/-10 days
Rates of Surgery for SVT
Time frame: 90 +/-10 days
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Gemeinschaftspraxis Mietaschk, Bilderling, Kaiser, Tato
München, Bavaria, Germany
Chriurgische Praxisklinik
Baesweiler, North Rhine-Westphalia, Germany
Krankenhaus Dresden-Friedrichstadt
Dresden, Saxony, Germany
Universitätsklinikum Dresden
Dresden, Saxony, Germany
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Görlitz, Saxony, Germany
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Berlin, Germany
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...and 13 more locations