Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux

NCT ID: NCT01499953

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 472 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2016-05-31

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

Conditions

Superficial Vein Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rivaroxaban

Rivaroxaban for 45 days oral dose: 10 mg OD

Group Type: EXPERIMENTAL

Rivaroxaban

Intervention Type: DRUG

Dose: 10 mg Duration: 45 (±5) days Frequency: once daily Application: oral

Fondaparinux

Fondaparinux for 45 days subcutaneous application: 2,5 mg OD

Group Type: ACTIVE_COMPARATOR

Fondaparinux

Intervention Type: DRUG

Fondaparinux Dose: 2.5 mg Duration: 45 (±5) days Frequency: once daily Application: subcutaneous

Interventions

Rivaroxaban

Dose: 10 mg Duration: 45 (±5) days Frequency: once daily Application: oral

Intervention Type: DRUG

Fondaparinux

Fondaparinux Dose: 2.5 mg Duration: 45 (±5) days Frequency: once daily Application: subcutaneous

Intervention Type: DRUG

Other Intervention Names

Xarelto; Arixtra

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

GWT-TUD GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Beyer-Westendorf, MD

Role: PRINCIPAL_INVESTIGATOR

on behalf of GWT-TUD GmbH

Locations

Hautarztpraxis

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Gemeinschaftspraxis Mietaschk, Bilderling, Kaiser, Tato

München, Bavaria, Germany

Chriurgische Praxisklinik

Baesweiler, North Rhine-Westphalia, Germany

Krankenhaus Dresden-Friedrichstadt

Dresden, Saxony, Germany

Universitätsklinikum Dresden

Dresden, Saxony, Germany

Oberlausitz-Gefäßpraxis

Görlitz, Saxony, Germany

Franziskus-Krankenhaus Berlin

Berlin, , Germany

MVZ Ramdohr, Praxis für Cardiovaskulär- u. Ultraschalldiagnostik

Berlin, , Germany

Praxis für Chirurgie & Gefäßmedizin

Berlin, , Germany

Praxis für Allgemeinmedizin und Phlebologie

Cologne, , Germany

Klinikum Darmstadt GmbH

Darmstadt, , Germany

Gemeinschaftspraxis Eggeling und Winter

Eschwege, , Germany

Asklepios Westklinikum Hamburg

Hamburg, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Internistische Praxisgemeinschaft

Hoppegarten, , Germany

Akademie für Gefäßkrankheiten e.V.

Karlsbach, , Germany

Universitätsklinikum Leipzig AöR Innere Medizin - Angiologische Ambulanz

Leipzig, , Germany

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, , Germany

Praxis Dr. Franke

Magdeburg, , Germany

Kardiologie Mühldorf am Inn

Mühldorf, , Germany

Praxis Dr. Kähler

Rostock, , Germany

Praxis für Gefäßmedizin am Tegernsee

Rottach-Egern, , Germany

Venenzentrum Wiesbaden

Wiesbaden, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 33368114 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28219692 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26973347 (View on PubMed)

Other Identifiers

SURPRISE-2011

Identifier Type: -

Identifier Source: org_study_id