Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GWT-TUD GmbH
• Collaborator: Bayer
• Treatments: Fondaparinux; PENTA; Rivaroxaban

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