Conditions: Superficial Vein Thrombosis
Keywords: superficial vein thrombosis thrombosis SVT
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 472
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of rivaroxaban versus fondaparinux in the treatment of superficial vein thrombosis (SVT).

Detailed description:
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

Arms:
arm 1: Rivaroxaban for 45 days oral dose: 10 mg OD arm 2: Fondaparinux for 45 days subcutaneous application: 2,5 mg OD

Interventions: intervention 1: Rivaroxaban intervention 2: Fondaparinux
Intervention descriptions: intervention 1: Dose: 10 mg Duration: 45 (±5) days Frequency: once daily Application: oral intervention 2: Fondaparinux Dose: 2.5 mg Duration: 45 (±5) days Frequency: once daily Application: subcutaneous

Protocol document: