Back to resultsSuperficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux
Primary Purpose
Superficial Vein Thrombosis
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Rivaroxaban
Fondaparinux
Sponsored by
About this trial
This is an interventional treatment trial for Superficial Vein Thrombosis focused on measuring superficial vein thrombosis, thrombosis, SVT
Eligibility 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
Sites / Locations
- Hautarztpraxis
- Gemeinschaftspraxis Mietaschk, Bilderling, Kaiser, Tato
- Chriurgische Praxisklinik
- Krankenhaus Dresden-Friedrichstadt
- Universitätsklinikum Dresden
- Oberlausitz-Gefäßpraxis
- Franziskus-Krankenhaus Berlin
- MVZ Ramdohr, Praxis für Cardiovaskulär- u. Ultraschalldiagnostik
- Praxis für Chirurgie & Gefäßmedizin
- Klinikum Darmstadt GmbH
- Gemeinschaftspraxis Eggeling und Winter
- Asklepios Westklinikum Hamburg
- Universitätsklinikum Heidelberg
- Internistische Praxisgemeinschaft
- Akademie für Gefäßkrankheiten e.V.
- Praxis für Allgemeinmedizin und Phlebologie
- Universitätsklinikum Leipzig AöR Innere Medizin - Angiologische Ambulanz
- Universitätsklinikum Schleswig-Holstein, Campus Lübeck
- Praxis Dr. Franke
- Kardiologie Mühldorf am Inn
- Praxis Dr. Kähler
- Praxis für Gefäßmedizin am Tegernsee
- Venenzentrum Wiesbaden
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rivaroxaban
Fondaparinux
Arm Description
Rivaroxaban for 45 days oral dose: 10 mg OD
Fondaparinux for 45 days subcutaneous application: 2,5 mg OD
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Composite Primary Efficacy Outcome
For this, secondary efficacy outcomes were the composite primary efficacy outcome up to Day 90 and the following outcomes up to Day 45 and Day 90: each component of the primary efficacy outcome, the rate of major VTE (composite of symptomatic pulmonary embolism or symptomatic proximal DVT or VTE-related death) and the rates of surgery for SVT.
Rate of Major VTE
composite of:
symptomatic pulmonary embolism
symptomatic proximal DVT
VTE-related death
Rates of Surgery for SVT
Full Information
NCT ID
NCT01499953
First Posted
December 19, 2011
Last Updated
July 18, 2022
Sponsor
GWT-TUD GmbH
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT01499953
Brief Title
Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux
Official Title
Superficial Vein Thrombosis (SVT) Treated for Forty-five Days With Rivaroxaban Versus Fondaparinux
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GWT-TUD GmbH
Collaborators
Bayer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superficial Vein Thrombosis
Keywords
superficial vein thrombosis, thrombosis, SVT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
472 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rivaroxaban
Arm Type
Experimental
Arm Description
Rivaroxaban for 45 days oral dose: 10 mg OD
Arm Title
Fondaparinux
Arm Type
Active Comparator
Arm Description
Fondaparinux for 45 days subcutaneous application: 2,5 mg OD
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Other Intervention Name(s)
Xarelto
Intervention Description
Dose: 10 mg Duration: 45 (±5) days Frequency: once daily Application: oral
Intervention Type
Drug
Intervention Name(s)
Fondaparinux
Other Intervention Name(s)
Arixtra
Intervention Description
Fondaparinux Dose: 2.5 mg Duration: 45 (±5) days Frequency: once daily Application: subcutaneous
Primary Outcome Measure Information:
Title
Rate of Objectively Confirmed VTE Complications
Description
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.
Time Frame
45 +/- 5 days
Secondary Outcome Measure Information:
Title
Composite Primary Efficacy Outcome
Description
For this, secondary efficacy outcomes were the composite primary efficacy outcome up to Day 90 and the following outcomes up to Day 45 and Day 90: each component of the primary efficacy outcome, the rate of major VTE (composite of symptomatic pulmonary embolism or symptomatic proximal DVT or VTE-related death) and the rates of surgery for SVT.
Time Frame
90 +/- 10 days
Title
Rate of Major VTE
Description
composite of:
symptomatic pulmonary embolism
symptomatic proximal DVT
VTE-related death
Time Frame
90 +/-10 days
Title
Rates of Surgery for SVT
Time Frame
90 +/-10 days
Other Pre-specified Outcome Measures:
Title
Major Bleeding (Main Safety Outcome)
Description
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.
Time Frame
45 +/- 5 days
Title
Clinically Relevant Non-major, Minor and Total (Any) Bleeding
Description
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)
Time Frame
45 +/- 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Beyer-Westendorf, MD
Organizational Affiliation
on behalf of GWT-TUD GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hautarztpraxis
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79098
Country
Germany
Facility Name
Gemeinschaftspraxis Mietaschk, Bilderling, Kaiser, Tato
City
München
State/Province
Bayern
ZIP/Postal Code
80331
Country
Germany
Facility Name
Chriurgische Praxisklinik
City
Baesweiler
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52499
Country
Germany
Facility Name
Krankenhaus Dresden-Friedrichstadt
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01067
Country
Germany
Facility Name
Universitätsklinikum Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Oberlausitz-Gefäßpraxis
City
Görlitz
State/Province
Sachsen
ZIP/Postal Code
02826
Country
Germany
Facility Name
Franziskus-Krankenhaus Berlin
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
MVZ Ramdohr, Praxis für Cardiovaskulär- u. Ultraschalldiagnostik
City
Berlin
ZIP/Postal Code
12043
Country
Germany
Facility Name
Praxis für Chirurgie & Gefäßmedizin
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
Klinikum Darmstadt GmbH
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Gemeinschaftspraxis Eggeling und Winter
City
Eschwege
ZIP/Postal Code
37269
Country
Germany
Facility Name
Asklepios Westklinikum Hamburg
City
Hamburg
ZIP/Postal Code
22559
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Internistische Praxisgemeinschaft
City
Hoppegarten
ZIP/Postal Code
15366
Country
Germany
Facility Name
Akademie für Gefäßkrankheiten e.V.
City
Karlsbach
ZIP/Postal Code
76307
Country
Germany
Facility Name
Praxis für Allgemeinmedizin und Phlebologie
City
Köln
ZIP/Postal Code
50670
Country
Germany
Facility Name
Universitätsklinikum Leipzig AöR Innere Medizin - Angiologische Ambulanz
City
Leipzig
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Praxis Dr. Franke
City
Magdeburg
ZIP/Postal Code
39112
Country
Germany
Facility Name
Kardiologie Mühldorf am Inn
City
Mühldorf Am Inn
ZIP/Postal Code
84453
Country
Germany
Facility Name
Praxis Dr. Kähler
City
Rostock
ZIP/Postal Code
18059
Country
Germany
Facility Name
Praxis für Gefäßmedizin am Tegernsee
City
Rottach-Egern
ZIP/Postal Code
83700
Country
Germany
Facility Name
Venenzentrum Wiesbaden
City
Wiesbaden
ZIP/Postal Code
65183
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
33368114
Citation
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.
Results Reference
derived
PubMed Identifier
28219692
Citation
Beyer-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.
Results Reference
derived
PubMed Identifier
26973347
Citation
Werth 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.
Results Reference
derived
Learn more about this trial
Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux
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