The purpose of this study is to evaluate the efficacy and safety of rivaroxaban versus
fondaparinux in the treatment of superficial vein thrombosis (SVT).
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Katja Reichardt, Dr., Phone: 004935125933, Ext: 188, Email: katja.reichardt@gwtonline.de
Deutsches Rotes Kreuz Schwesternschaft Berlin Gemeinnütziges Krankenhaus GmbH, Berlin 12559, Germany; Active, not recruiting
Franziskus-Krankenhaus Berlin, Berlin 10787, Germany; Recruiting
Christian Kirchhof, Dr. med.
MVZ Ramdohr, Praxis für Cardiovaskulär- u. Ultraschalldiagnostik, Berlin 12043, Germany; Recruiting
Claudia Zemmrich, MD
Claudia Zemmrich, Dr. med., Principal Investigator
Praxis für Chirurgie & Gefäßmedizin, Berlin 12627, Germany; Recruiting
Ulrich Ruppe, Dr. med., Principal Investigator
Ruhr-Universität Bochum im St. Maria-Hilf Krankenhaus Venenzentrum Dermatologie - Gefäßchirurgie, Bochum, Germany; Active, not recruiting
Universitäts-Hautklinik Bonn, Bonn 53105, Germany; Active, not recruiting
Klinikum Darmstadt GmbH, Darmstadt 64283, Germany; Active, not recruiting
Gemeinschaftspraxis Eggeling und Winter, Eschwege 37269, Germany; Recruiting
Torsten Eggeling, MD, Principal Investigator
Asklepios Westklinikum Hamburg, Hamburg 22559, Germany; Completed
Universitätsklinikum Heidelberg, Heidelberg 69120, Germany; Recruiting
Manuela Licka, MD, Principal Investigator
Ivo Licka, Sub-Investigator
Internistische Praxisgemeinschaft, Hoppegarten 15366, Germany; Recruiting
Antita Demmig, Dr. med., Principal Investigator
Akademie für Gefäßkrankheiten e.V., Karlsbach 76307, Germany; Recruiting
Uwe Zwettler, MD, Principal Investigator
Curt H. Diehm, MD, Sub-Investigator
Alessandro Pira, MD, Sub-Investigator
SRH Klinikum Karlsbad-Langensteinbach GmbH, Karlsbad, Germany; Active, not recruiting
Praxis für Allgemeinmedizin un dPhlebologie, Köln 50670, Germany; Recruiting
Renate Murena-Schmidt, MD, Principal Investigator
Universitätsklinikum Leipzig AöR Innere Medizin - Angiologische Ambulanz, Leipzig, Germany; Recruiting
Katja Mühlberg, Dr. med.
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck 23538, Germany; Recruiting
Birgit Kahle, MD, Principal Investigator
Praxis Dr. Franke, Magdeburg 39112, Germany; Completed
Universitätsmedizin Mainz /Zentrum für klin. Studien, Mainz, Germany; Active, not recruiting
Kardiologie Mühldorf am Inn, Mühldorf am Inn 84453, Germany; Recruiting
Norbert Schön, MD
Norbert Schön, MD, Principal Investigator
Brigitte Schön, MD, Sub-Investigator
Klinikum der Universität München / Angiologie, München, Germany; Active, not recruiting
Praxis Dr. Kähler, Rostock 18059, Germany; Recruiting
Wolfgang Kähler, MD, Principal Investigator
Heinrich Prophet, MD, Sub-Investigator
Praxis für Gefäßmedizin am Tegernsee, Rottach-Egern 83700, Germany; Recruiting
Franz X. Breu, MD, Principal Investigator
Venezentrum Wiesbaden, Wiesbaden 65183, Germany; Recruiting
Detlef Schulte-Hürmann, Dr. med.
Detlef Schulte-Hürmann, Dr. med., Principal Investigator
Hautarztpraxis, Freiburg, Baden-Württemberg 79098, Germany; Recruiting
Rahel Pfister, MD, Principal Investigator
Gemeinschaftspraxis Mietaschk, Bilderling, Kaiser, Tato, München, Bayern 80331, Germany; Recruiting
Frederico Tato, Prof., Principal Investigator
Peter Baron von Bilderlin, MD, Sub-Investigator
Wolfram P. Kaiser, MD, Sub-Investigator
Chriurgische Praxisklinik, Baesweiler, Nordrhein-Westfalen 52499, Germany; Recruiting
Jürgen Frank, MD
Jürgen Frank, MD, Principal Investigator
Krankenhaus Dresden-Friedrichstadt, Dresden, Sachsen 01067, Germany; Recruiting
Sebastian Schellong, PhD, Phone: 00490351480, Ext: 1120, Email: Schellong-se@khdf.de
Sebastian Schellong, PhD, Principal Investigator
Pomper Lutz, MD, Sub-Investigator
Birgit Voigts, MD, Sub-Investigator
Universitätsklinikum Dresden, Dresden, Sachsen 01307, Germany; Recruiting
Jan Beyer-Westendorf, MD, Phone: 0049351458, Ext: 3659, Email: Beyer.Jan@uniklinikum-dresden.de
Jan Beyer-Westendorf, MD, Principal Investigator
Kai Halbritter, MD, Sub-Investigator
Christiane Naue, MD, Sub-Investigator
Christine Schmidt, MD, Sub-Investigator
Sebastian Werth, Sub-Investigator
Christian Köhler, Sub-Investigator
Oberlausitz-Gefäßpraxis, Görlitz, Sachsen 02826, Germany; Recruiting
Wolfram Oettler, MD, Phone: 00493581316026, Email: info@ol-gefaesspraxis.de
Wolfram Oettler, MD, Principal Investigator