Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux

Superficial Vein Thrombosis Clinical Trial

Official title:

Superficial Vein Thrombosis (SVT) Treated for Forty-five Days With Rivaroxaban Versus Fondaparinux

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499953
• Other study ID #: SURPRISE-2011
• Status: Completed
• Phase: Phase 3
• Start date: April 2012
• Est. completion date: May 2016

Study information

• Verified date: July 2022
• Source: GWT-TUD GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Superficial Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Rivaroxaban
Dose: 10 mg Duration: 45 (±5) days Frequency: once daily Application: oral
• Fondaparinux
Fondaparinux Dose: 2.5 mg Duration: 45 (±5) days Frequency: once daily Application: subcutaneous

Locations

Country	Name	City	State
Germany	Chriurgische Praxisklinik	Baesweiler	Nordrhein-Westfalen
Germany	Franziskus-Krankenhaus Berlin	Berlin
Germany	MVZ Ramdohr, Praxis für Cardiovaskulär- u. Ultraschalldiagnostik	Berlin
Germany	Praxis für Chirurgie & Gefäßmedizin	Berlin
Germany	Klinikum Darmstadt GmbH	Darmstadt
Germany	Krankenhaus Dresden-Friedrichstadt	Dresden	Sachsen
Germany	Universitätsklinikum Dresden	Dresden	Sachsen
Germany	Gemeinschaftspraxis Eggeling und Winter	Eschwege
Germany	Hautarztpraxis	Freiburg	Baden-Württemberg
Germany	Oberlausitz-Gefäßpraxis	Görlitz	Sachsen
Germany	Asklepios Westklinikum Hamburg	Hamburg
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Internistische Praxisgemeinschaft	Hoppegarten
Germany	Akademie für Gefäßkrankheiten e.V.	Karlsbach
Germany	Praxis für Allgemeinmedizin und Phlebologie	Köln
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 Am Inn
Germany	Gemeinschaftspraxis Mietaschk, Bilderling, Kaiser, Tato	München	Bayern
Germany	Praxis Dr. Kähler	Rostock
Germany	Praxis für Gefäßmedizin am Tegernsee	Rottach-Egern
Germany	Venenzentrum Wiesbaden	Wiesbaden

Sponsors (2)

Lead Sponsor	Collaborator
GWT-TUD GmbH	Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major Bleeding (Main Safety Outcome)	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.	45 +/- 5 days
Other	Clinically Relevant Non-major, Minor and Total (Any) Bleeding	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)	45 +/- 5 days
Primary	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	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.	90 +/- 10 days
Secondary	Rate of Major VTE	composite of: symptomatic pulmonary embolism; symptomatic proximal DVT; VTE-related death	90 +/-10 days
Secondary	Rates of Surgery for SVT		90 +/-10 days