Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by GWT-TUD GmbH
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
GWT-TUD GmbH
ClinicalTrials.gov Identifier:
NCT01499953
First received: December 19, 2011
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to evaluate the efficacy and safety of rivaroxaban versus fondaparinux in the treatment of superficial vein thrombosis (SVT).


Condition Intervention Phase
Superficial Vein Thrombosis
Drug: Rivaroxaban
Drug: Fondaparinux
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Superficial Vein Thrombosis (SVT) Treated for Forty-five Days With Rivaroxaban Versus Fondaparinux

Resource links provided by NLM:


Further study details as provided by GWT-TUD GmbH:

Primary Outcome Measures:
  • number of major bleedings [ Time Frame: 45 +/- 5 days ] [ Designated as safety issue: Yes ]
    occurrence of major bleeding defined as an overt bleeding and associated with a fall of hemoglobin >2 g/l, or leading to a transfusion of >2 units of packed red blood cells or whole blood, or occurring into a critical location such as intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or fatal bleeding

  • number of deaths from any cause [ Time Frame: 45 +/- 5 days ] [ Designated as safety issue: No ]
    occurence of death: 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)


Secondary Outcome Measures:
  • major bleeding [ Time Frame: 90 +/- 10 days ] [ Designated as safety issue: Yes ]

    The main safety outcome will be major bleeding, defined as an overt bleeding and

    • associated with a fall of hemoglobin of 2 g/l or more, or
    • leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or
    • occurring into a critical location such as intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or
    • fatal bleeding

  • death from any cause [ Time Frame: 90 +/-10 days ] [ Designated as safety issue: No ]
    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 90 (+/- 10 days)

  • rate of major VTE [ Time Frame: 90 +/-10 days ] [ Designated as safety issue: No ]
    composite of symptomatic pulmonary embolism or symptomatic proximal DVT or VTE-related death

  • rates of surgery for SVT [ Time Frame: 90 +/-10 days ] [ Designated as safety issue: No ]
  • clinically relevant non-major, minor and total (any) bleeding [ Time Frame: 90 +/-10 days ] [ Designated as safety issue: Yes ]

    Clinically relevant, non-major bleeding is defined as any overt bleeding and

    • associated with a medical intervention, or
    • unscheduled contact with the physician (presence or telephone contact)
    • temporary or complete cessation of study drug
    • associated with any relevant discomfort to the patient (pain, impairment of activities of daily life)


Estimated Enrollment: 506
Study Start Date: April 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rivaroxaban
Rivaroxaban for 45 days oral dose: 10 mg OD
Drug: Rivaroxaban
Dose: 10 mg Duration: 45 (±5) days Frequency: once daily Application: oral
Other Name: Xarelto
Active Comparator: Fondaparinux
Fondaparinux for 45 days subcutaneous application: 2,5 mg OD
Drug: Fondaparinux
Fondaparinux Dose: 2.5 mg Duration: 45 (±5) days Frequency: once daily Application: subcutaneous
Other Name: Arixtra

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499953

Contacts
Contact: Katja Reichardt, Dr. 004935125933 ext 188 katja.reichardt@gwtonline.de
Contact: Martina Schulze 004935125933 ext 186 martina.schulze@gwtonline.de

Locations
Germany
Hautarztpraxis Recruiting
Freiburg, Baden-Württemberg, Germany, 79098
Principal Investigator: Rahel Pfister, MD         
Gemeinschaftspraxis Mietaschk, Bilderling, Kaiser, Tato Recruiting
München, Bayern, Germany, 80331
Principal Investigator: Andreas Mietaschk, MD         
Sub-Investigator: Peter Baron von Bilderlin, MD         
Sub-Investigator: Wolfram P. Kaiser, MD         
Sub-Investigator: Frederico Tato, PhD         
Chriurgische Praxisklinik Recruiting
Baesweiler, Nordrhein-Westfalen, Germany, 52499
Contact: Jürgen Frank, MD         
Principal Investigator: Jürgen Frank, MD         
Krankenhaus Dresden-Friedrichstadt Recruiting
Dresden, Sachsen, Germany, 01067
Contact: Sebastian Schellong, PhD    00490351480 ext 1120    Schellong-se@khdf.de   
Principal Investigator: Sebastian Schellong, PhD         
Sub-Investigator: Pomper Lutz, MD         
Sub-Investigator: Birgit Voigts, MD         
Universitätsklinikum Dresden Recruiting
Dresden, Sachsen, Germany, 01307
Contact: Jan Beyer-Westendorf, MD    0049351458 ext 3659    Beyer.Jan@uniklinikum-dresden.de   
Principal Investigator: Jan Beyer-Westendorf, MD         
Sub-Investigator: Kai Halbritter, MD         
Sub-Investigator: Christiane Naue, MD         
Sub-Investigator: Christine Schmidt, MD         
Sub-Investigator: Sebastian Werth         
Sub-Investigator: Christian Köhler         
Oberlausitz-Gefäßpraxis Recruiting
Görlitz, Sachsen, Germany, 02826
Contact: Wolfram Oettler, MD    00493581316026    info@ol-gefaesspraxis.de   
Principal Investigator: Wolfram Oettler, MD         
Praxis für Chirurgie & Gefäßmedizin Recruiting
Berlin, Germany, 12627
Principal Investigator: Ulrich Ruppe, Dr. med.         
Deutsches Rotes Kreuz Schwesternschaft Berlin Gemeinnütziges Krankenhaus GmbH Active, not recruiting
Berlin, Germany, 12559
MVZ Ramdohr, Praxis für Cardiovaskulär- u. Ultraschalldiagnostik Recruiting
Berlin, Germany, 12043
Contact: Claudia Zemmrich, MD         
Principal Investigator: Claudia Zemmrich, Dr. med.         
Franziskus-Krankenhaus Berlin Recruiting
Berlin, Germany, 10787
Principal Investigator: André Schmidt-Lucke, Prof. Dr.         
Universitäts-Hautklinik Bonn Active, not recruiting
Bonn, Germany, 53105
Klinikum Darmstadt GmbH Active, not recruiting
Darmstadt, Germany, 64283
Gemeinschaftspraxis Eggeling und Winter Recruiting
Eschwege, Germany, 37269
Principal Investigator: Torsten Eggeling, MD         
Asklepios Westklinikum Hamburg Recruiting
Hamburg, Germany, 22559
Principal Investigator: Holger Lawall, Dr. med.         
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Principal Investigator: Manuela Licka, MD         
Sub-Investigator: Ivo Licka         
Internistische Praxisgemeinschaft Recruiting
Hoppegarten, Germany, 15366
Principal Investigator: Antita Demmig, Dr. med.         
Akademie für Gefäßkrankheiten e.V. Recruiting
Karlsbach, Germany, 76307
Principal Investigator: Uwe Zwettler, MD         
Sub-Investigator: Curt H. Diehm, MD         
Sub-Investigator: Alessandro Pira, MD         
Praxis für Allgemeinmedizin un dPhlebologie Recruiting
Köln, Germany, 50670
Principal Investigator: Renate Murena-Schmidt, MD         
Universitätsklinikum Schleswig-Holstein, Campus Lübeck Recruiting
Lübeck, Germany, 23538
Principal Investigator: Birgit Kahle, MD         
Praxis Dr. Franke Recruiting
Magdeburg, Germany, 39112
Principal Investigator: Dirk Franke, MD         
Kardiologie Mühldorf am Inn Recruiting
Mühldorf am Inn, Germany, 84453
Contact: Norbert Schön, MD         
Principal Investigator: Norbert Schön, MD         
Sub-Investigator: Brigitte Schön, MD         
Praxis Dr. Kähler Recruiting
Rostock, Germany, 18059
Principal Investigator: Wolfgang Kähler, MD         
Sub-Investigator: Heinrich Prophet, MD         
Praxis für Gefäßmedizin am Tegernsee Recruiting
Rottach-Egern, Germany, 83700
Principal Investigator: Franz X. Breu, MD         
Venezentrum Wiesbaden Recruiting
Wiesbaden, Germany, 65183
Contact: Detlef Schulte-Hürmann, Dr. med.         
Principal Investigator: Detlef Schulte-Hürmann, Dr. med.         
Sponsors and Collaborators
GWT-TUD GmbH
Bayer
Investigators
Principal Investigator: Jan Beyer-Westendorf, MD on behalf of GWT-TUD GmbH
  More Information

No publications provided

Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT01499953     History of Changes
Other Study ID Numbers: SURPRISE-2011
Study First Received: December 19, 2011
Last Updated: January 17, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GWT-TUD GmbH:
superficial vein thrombosis
thrombosis
SVT

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases
Fondaparinux
PENTA
Rivaroxaban
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014