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Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux

Information source: GWT-TUD GmbH
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Superficial Vein Thrombosis

Intervention: Rivaroxaban (Drug); Fondaparinux (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: GWT-TUD GmbH

Official(s) and/or principal investigator(s):
Jan Beyer-Westendorf, MD, Principal Investigator, Affiliation: on behalf of GWT-TUD GmbH

Overall contact:
Katja Reichardt, Dr., Phone: 004935125933, Ext: 188, Email: katja.reichardt@gwtonline.de

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

number of major bleedings

number of deaths from any cause

Secondary outcome:

major bleeding

death from any cause

rate of major VTE

rates of surgery for SVT

clinically relevant non-major, minor and total (any) bleeding

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Additional Information

Starting date: April 2012
Last updated: July 24, 2015

Page last updated: August 23, 2015

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