Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux
Condition: Superficial Vein Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Intervention: Rivaroxaban; Fondaparinux
Intervention description: 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
Intervention MeSH terms: PENTA; Rivaroxaban; Fondaparinux
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 472.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: superficial vein thrombosis; thrombosis; SVT

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  acute symptomatic supragenual superficial vein thrombosis of the leg

          -  at least one of the following major risk factor for VTE:

          -  age > 65 years or

          -  male sex or

          -  history of DVT/PE/SVT or

          -  history of cancer or active cancer or

          -  autoimmune disease or

          -  SVT of a non-varicose vein

          -  thrombus extension of at least 5 cm

          -  proximal thrombus end with more than 3 cm distance to the saphenofemoral junction
             (SFJ)

          -  age > 18 years

          -  written informed consent

        Exclusion Criteria:

          -  other indication for therapeutic anticoagulation such as acute deep vein thrombosis,
             acute pulmonary embolism, atrial fibrillation with indication for anticoagulant
             therapy

          -  any PE or DVT within last 6 months before inclusion

          -  clinical signs of PE without objective exclusion (CT or VQ scan, angiography)

          -  SVT without signs of thrombotic/inflammatory activity (activity signs: diameter > 4
             mm, pain, redness, elevated local or systemic temperature)

          -  SVT after sclerotherapy

          -  Duration of symptoms > 3 weeks

          -  pretreatment of more than 72 h with therapeutic dosages of oral or parenteral
             anticoagulants

          -  pretreatment of more than 5 days with subtherapeutic oral or parenteral anticoagulants

          -  indication for escalated antiplatelet therapy (monotherapy with aspirin > 325 g/d and
             any dual antiplatelet therapy)

          -  SVT closer than 3 cm to saphenofemoral junction (SVJ)

          -  anticipated superficial vein surgery within 90 days

          -  anticipated thrombolytic therapy within 90 days

          -  manifest clinically relevant bleeding

          -  clinically relevant bleeding in the last 30 days before study inclusion

          -  major surgery within last 30 days before inclusion

          -  ophthalmic, spinal or cerebral surgery within last 90 days

          -  severe head trauma within last 90 days

          -  hemorrhagic stroke within last 12 months

          -  hereditary or acquired severe hemorrhagic diathesis

          -  gastrointestinal bleeding within last 90 days requiring endoscopy

          -  uncontrolled arterial hypertension (systolic > 180 mm Hg, diastolic > 110 mm Hg)

          -  acute endocarditis

          -  low platelet count (< 100 x 109/l)

          -  Prothrombin time < 50 %

          -  calculated creatinine clearance < 30 ml/min

          -  significant liver disease such as acute hepatitis, chronic active hepatitis, cirrhosis

          -  life expectancy < 3 months

          -  any contraindications listed for rivaroxaban or fondaparinux

          -  women of child bearing potential without safe contraception method

          -  pregnant or breastfeeding women

          -  participation in another trial with pharmacological intervention