Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux
- Conditions
- Superficial Vein Thrombosis
- Interventions
- Registration Number
- NCT01499953
- Lead Sponsor
- GWT-TUD GmbH
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 472
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rivaroxaban Rivaroxaban Rivaroxaban for 45 days oral dose: 10 mg OD Fondaparinux Fondaparinux Fondaparinux for 45 days subcutaneous application: 2,5 mg OD
- Primary Outcome Measures
Name Time Method Rate of Objectively Confirmed VTE Complications 45 +/- 5 days 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.
- Secondary Outcome Measures
Name Time Method Rates of Surgery for SVT 90 +/-10 days Rate of Major VTE 90 +/-10 days composite of:
* symptomatic pulmonary embolism
* symptomatic proximal DVT
* VTE-related deathComposite Primary Efficacy Outcome 90 +/- 10 days 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.
Trial Locations
- Locations (23)
Universitätsklinikum Dresden
🇩🇪Dresden, Sachsen, Germany
MVZ Ramdohr, Praxis für Cardiovaskulär- u. Ultraschalldiagnostik
🇩🇪Berlin, Germany
Franziskus-Krankenhaus Berlin
🇩🇪Berlin, Germany
Gemeinschaftspraxis Mietaschk, Bilderling, Kaiser, Tato
🇩🇪München, Bayern, Germany
Internistische Praxisgemeinschaft
🇩🇪Hoppegarten, Germany
Kardiologie Mühldorf am Inn
🇩🇪Mühldorf Am Inn, Germany
Krankenhaus Dresden-Friedrichstadt
🇩🇪Dresden, Sachsen, Germany
Hautarztpraxis
🇩🇪Freiburg, Baden-Württemberg, Germany
Asklepios Westklinikum Hamburg
🇩🇪Hamburg, Germany
Klinikum Darmstadt GmbH
🇩🇪Darmstadt, Germany
Praxis Dr. Franke
🇩🇪Magdeburg, Germany
Chriurgische Praxisklinik
🇩🇪Baesweiler, Nordrhein-Westfalen, Germany
Oberlausitz-Gefäßpraxis
🇩🇪Görlitz, Sachsen, Germany
Praxis Dr. Kähler
🇩🇪Rostock, Germany
Praxis für Gefäßmedizin am Tegernsee
🇩🇪Rottach-Egern, Germany
Universitätsklinikum Leipzig AöR Innere Medizin - Angiologische Ambulanz
🇩🇪Leipzig, Germany
Gemeinschaftspraxis Eggeling und Winter
🇩🇪Eschwege, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Akademie für Gefäßkrankheiten e.V.
🇩🇪Karlsbach, Germany
Praxis für Allgemeinmedizin und Phlebologie
🇩🇪Köln, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
🇩🇪Lübeck, Germany
Venenzentrum Wiesbaden
🇩🇪Wiesbaden, Germany
Praxis für Chirurgie & Gefäßmedizin
🇩🇪Berlin, Germany