Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
GWT-TUD GmbH
ClinicalTrials.gov Identifier:
NCT01499953
First received: December 19, 2011
Last updated: August 8, 2016
Last verified: August 2016
  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)


Enrollment: 476
Study Start Date: April 2012
Study Completion Date: June 2016
Primary Completion Date: June 2016 (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   (Adult, Senior)
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

Locations
Germany
Hautarztpraxis
Freiburg, Baden-Württemberg, Germany, 79098
Gemeinschaftspraxis Mietaschk, Bilderling, Kaiser, Tato
München, Bayern, Germany, 80331
Chriurgische Praxisklinik
Baesweiler, Nordrhein-Westfalen, Germany, 52499
Krankenhaus Dresden-Friedrichstadt
Dresden, Sachsen, Germany, 01067
Universitätsklinikum Dresden
Dresden, Sachsen, Germany, 01307
Oberlausitz-Gefäßpraxis
Görlitz, Sachsen, Germany, 02826
Franziskus-Krankenhaus Berlin
Berlin, Germany, 10787
MVZ Ramdohr, Praxis für Cardiovaskulär- u. Ultraschalldiagnostik
Berlin, Germany, 12043
Deutsches Rotes Kreuz Schwesternschaft Berlin Gemeinnütziges Krankenhaus GmbH
Berlin, Germany, 12559
Praxis für Chirurgie & Gefäßmedizin
Berlin, Germany, 12627
Klinikum Darmstadt GmbH
Darmstadt, Germany, 64283
Gemeinschaftspraxis Eggeling und Winter
Eschwege, Germany, 37269
Asklepios Westklinikum Hamburg
Hamburg, Germany, 22559
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Internistische Praxisgemeinschaft
Hoppegarten, Germany, 15366
Akademie für Gefäßkrankheiten e.V.
Karlsbach, Germany, 76307
Praxis für Allgemeinmedizin und Phlebologie
Köln, Germany, 50670
Universitätsklinikum Leipzig AöR Innere Medizin - Angiologische Ambulanz
Leipzig, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, Germany, 23538
Praxis Dr. Franke
Magdeburg, Germany, 39112
Kardiologie Mühldorf am Inn
Mühldorf am Inn, Germany, 84453
Praxis Dr. Kähler
Rostock, Germany, 18059
Praxis für Gefäßmedizin am Tegernsee
Rottach-Egern, Germany, 83700
Venenzentrum Wiesbaden
Wiesbaden, Germany, 65183
Sponsors and Collaborators
GWT-TUD GmbH
Bayer
Investigators
Principal Investigator: Jan Beyer-Westendorf, MD on behalf of GWT-TUD GmbH
  More Information

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: August 8, 2016
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
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Fondaparinux
PENTA
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents

ClinicalTrials.gov processed this record on August 25, 2016