Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux

Study Overview
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Brief Summary
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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
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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

Official Title
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Superficial Vein Thrombosis (SVT) Treated for Forty-five Days With Rivaroxaban Versus Fondaparinux

Conditions
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Superficial Vein Thrombosis

Intervention / Treatment
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* Drug: Rivaroxaban
* Drug: Fondaparinux


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rivaroxaban<br>Rivaroxaban for 45 days oral dose: 10 mg OD | Drug: Rivaroxaban<br>* Dose: 10 mg Duration: 45 (±5) days Frequency: once daily Application: oral<br>* Other names: Xarelto;|
| Active Comparator: Fondaparinux<br>Fondaparinux for 45 days subcutaneous application: 2,5 mg OD | Drug: Fondaparinux<br>* Fondaparinux Dose: 2.5 mg Duration: 45 (±5) days Frequency: once daily Application: subcutaneous<br>* Other names: Arixtra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 45 +/- 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 90 +/- 10 days | 
| Rate of Major VTE | composite of: symptomatic pulmonary embolism symptomatic proximal DVT VTE-related death | 90 +/-10 days | 
| Rates of Surgery for SVT |  | 90 +/-10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SVT, superficial vein thrombosis, thrombosis