Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux
1 other identifier
interventional
472
1 country
23
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2012
Typical duration for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2011
CompletedFirst Posted
Study publicly available on registry
December 26, 2011
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
May 15, 2023
CompletedMay 15, 2023
July 1, 2022
4.1 years
December 19, 2011
March 21, 2018
July 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Objectively Confirmed VTE Complications
The primary efficacy outcome was the composite of death from any cause, 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 45.
45 +/- 5 days
Secondary Outcomes (3)
Composite Primary Efficacy Outcome
90 +/- 10 days
Rate of Major VTE
90 +/-10 days
Rates of Surgery for SVT
90 +/-10 days
Other Outcomes (2)
Major Bleeding (Main Safety Outcome)
45 +/- 5 days
Clinically Relevant Non-major, Minor and Total (Any) Bleeding
45 +/- 5 days
Study Arms (2)
Rivaroxaban
EXPERIMENTALRivaroxaban for 45 days oral dose: 10 mg OD
Fondaparinux
ACTIVE COMPARATORFondaparinux for 45 days subcutaneous application: 2,5 mg OD
Interventions
Dose: 10 mg Duration: 45 (±5) days Frequency: once daily Application: oral
Fondaparinux Dose: 2.5 mg Duration: 45 (±5) days Frequency: once daily Application: subcutaneous
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- other indication for therapeutic anticoagulation such as acute deep vein thrombosis, acute pulmonary embolism, atrial fibrillation with indication for anticoagulant therapy
- 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
- 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
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GWT-TUD GmbHlead
- Bayercollaborator
Study Sites (23)
Hautarztpraxis
Freiburg im Breisgau, Baden-Wurttemberg, 79098, Germany
Gemeinschaftspraxis Mietaschk, Bilderling, Kaiser, Tato
München, Bavaria, 80331, Germany
Chriurgische Praxisklinik
Baesweiler, North Rhine-Westphalia, 52499, Germany
Krankenhaus Dresden-Friedrichstadt
Dresden, Saxony, 01067, Germany
Universitätsklinikum Dresden
Dresden, Saxony, 01307, Germany
Oberlausitz-Gefäßpraxis
Görlitz, Saxony, 02826, Germany
Franziskus-Krankenhaus Berlin
Berlin, 10787, Germany
MVZ Ramdohr, Praxis für Cardiovaskulär- u. Ultraschalldiagnostik
Berlin, 12043, Germany
Praxis für Chirurgie & Gefäßmedizin
Berlin, 12627, Germany
Praxis für Allgemeinmedizin und Phlebologie
Cologne, 50670, Germany
Klinikum Darmstadt GmbH
Darmstadt, 64283, Germany
Gemeinschaftspraxis Eggeling und Winter
Eschwege, 37269, Germany
Asklepios Westklinikum Hamburg
Hamburg, 22559, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Internistische Praxisgemeinschaft
Hoppegarten, 15366, Germany
Akademie für Gefäßkrankheiten e.V.
Karlsbach, 76307, Germany
Universitätsklinikum Leipzig AöR Innere Medizin - Angiologische Ambulanz
Leipzig, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538, Germany
Praxis Dr. Franke
Magdeburg, 39112, Germany
Kardiologie Mühldorf am Inn
Mühldorf, 84453, Germany
Praxis Dr. Kähler
Rostock, 18059, Germany
Praxis für Gefäßmedizin am Tegernsee
Rottach-Egern, 83700, Germany
Venenzentrum Wiesbaden
Wiesbaden, 65183, Germany
Related Publications (3)
Kearon C, Carrier M, Gu CS, Schulman S, Bates SM, Kahn SR, Chagnon I, Nguyen DT, Wu C, Rudd-Scott L, Julian JA. Rivaroxaban Compared to Placebo for the Treatment of Leg Superficial Vein Thrombosis: A Randomized Trial. Semin Thromb Hemost. 2020 Nov;46(8):977-985. doi: 10.1055/s-0040-1718891. Epub 2020 Dec 23.
PMID: 33368114DERIVEDBeyer-Westendorf J, Schellong SM, Gerlach H, Rabe E, Weitz JI, Jersemann K, Sahin K, Bauersachs R; SURPRISE investigators. Prevention of thromboembolic complications in patients with superficial-vein thrombosis given rivaroxaban or fondaparinux: the open-label, randomised, non-inferiority SURPRISE phase 3b trial. Lancet Haematol. 2017 Mar;4(3):e105-e113. doi: 10.1016/S2352-3026(17)30014-5. Epub 2017 Feb 16.
PMID: 28219692DERIVEDWerth S, Bauersachs R, Gerlach H, Rabe E, Schellong S, Beyer-Westendorf J. Superficial vein thrombosis treated for 45 days with rivaroxaban versus fondaparinux: rationale and design of the SURPRISE trial. J Thromb Thrombolysis. 2016 Aug;42(2):197-204. doi: 10.1007/s11239-016-1354-3.
PMID: 26973347DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- PD Dr. med. Jan Beyer-Westendorf
- Organization
- University Hospital Dresden, Centre for Vascular Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Beyer-Westendorf, MD
on behalf of GWT-TUD GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2011
First Posted
December 26, 2011
Study Start
April 1, 2012
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
May 15, 2023
Results First Posted
May 15, 2023
Record last verified: 2022-07