Clinical trial NCT01499953: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Superficial Vein Thrombosis
Keywords: superficial vein thrombosis
thrombosis
SVT
Lead sponsor: GWT-TUD GmbH
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2011-12-26
Enrollment: 472
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Rate of Objectively Confirmed VTE Complications
timeFrame: 45 +/- 5 days
Secondary outcomes:
measure: Composite Primary Efficacy Outcome
timeFrame: 90 +/- 10 days
measure: Rate of Major VTE
timeFrame: 90 +/-10 days
measure: Rates of Surgery for SVT
timeFrame: 90 +/-10 days
Other outcomes:
measure: Major Bleeding (Main Safety Outcome)
timeFrame: 45 +/- 5 days
measure: Clinically Relevant Non-major, Minor and Total (Any) Bleeding
timeFrame: 45 +/- 5 days
Locations:
city: Freiburg
country: Germany
facility: Hautarztpraxis
state: Baden-Württemberg
city: München
country: Germany
facility: Gemeinschaftspraxis Mietaschk, Bilderling, Kaiser, Tato
state: Bayern
city: Baesweiler
country: Germany
facility: Chriurgische Praxisklinik
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Krankenhaus Dresden-Friedrichstadt
state: Sachsen
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
state: Sachsen
city: Görlitz
country: Germany
facility: Oberlausitz-Gefäßpraxis
state: Sachsen
city: Berlin
country: Germany
facility: Franziskus-Krankenhaus Berlin
city: Berlin
country: Germany
facility: MVZ Ramdohr, Praxis für Cardiovaskulär- u. Ultraschalldiagnostik
city: Berlin
country: Germany
facility: Praxis für Chirurgie & Gefäßmedizin
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt GmbH
city: Eschwege
country: Germany
facility: Gemeinschaftspraxis Eggeling und Winter
city: Hamburg
country: Germany
facility: Asklepios Westklinikum Hamburg
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Hoppegarten
country: Germany
facility: Internistische Praxisgemeinschaft
city: Karlsbach
country: Germany
facility: Akademie für Gefäßkrankheiten e.V.
city: Köln
country: Germany
facility: Praxis für Allgemeinmedizin und Phlebologie
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR Innere Medizin - Angiologische Ambulanz
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck
city: Magdeburg
country: Germany
facility: Praxis Dr. Franke
city: Mühldorf Am Inn
country: Germany
facility: Kardiologie Mühldorf am Inn
city: Rostock
country: Germany
facility: Praxis Dr. Kähler
city: Rottach-Egern
country: Germany
facility: Praxis für Gefäßmedizin am Tegernsee
city: Wiesbaden
country: Germany
facility: Venenzentrum Wiesbaden
Study officials:
affiliation: on behalf of GWT-TUD GmbH
name: Jan Beyer-Westendorf, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.