Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01499953
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : September 13, 2016
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Superficial Vein Thrombosis Drug: Rivaroxaban Drug: Fondaparinux Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 472 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Superficial Vein Thrombosis (SVT) Treated for Forty-five Days With Rivaroxaban Versus Fondaparinux
Study Start Date : April 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Composit-Endpoint VTE [ Time Frame: 45 +/- 5 days ]

    Composite of

    • death from any cause
    • symptomatic pulmonary embolism
    • symptomatic deep vein thrombosis
    • symptomatic extension towards the saphenofemoral junction
    • symptomatic recurrence of superficial vein thrombosis

Secondary Outcome Measures :
  1. composite primary efficacy outcome [ Time Frame: 90 +/- 10 days ]
  2. each component of primary efficacy outcome up to day 45 and day 90 [ Time Frame: 90 +/-10 days ]
    • symptomatic pulmonary embolism
    • symptomatic deep vein thrombosis
    • symptomatic extension towards the saphenofemoral junction
    • symptomatic recurrence of superficial vein thrombosis
    • death from any cause

  3. rate of major VTE [ Time Frame: 90 +/-10 days ]

    composite of:

    • symptomatic pulmonary embolism
    • symptomatic proximal DVT
    • VTE-related death

  4. rates of surgery for SVT [ Time Frame: 90 +/-10 days ]

Other Outcome Measures:
  1. Major bleeding (Main safety outcome) [ Time Frame: 45 +/- 5 days ]
    • 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 site such as intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or;
    • fatal bleeding.

  2. clinically relevant non-major, minor and total (any) bleeding [ Time Frame: 45 +/- 5 days ]

    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)

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01499953

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
Görlitz, Sachsen, Germany, 02826
Franziskus-Krankenhaus Berlin
Berlin, Germany, 10787
MVZ Ramdohr, Praxis für Cardiovaskulär- u. Ultraschalldiagnostik
Berlin, Germany, 12043
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
Principal Investigator: Jan Beyer-Westendorf, MD on behalf of GWT-TUD GmbH

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: GWT-TUD GmbH Identifier: NCT01499953     History of Changes
Other Study ID Numbers: SURPRISE-2011
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016

Keywords provided by GWT-TUD GmbH:
superficial vein thrombosis

Additional relevant MeSH terms:
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents