Status:
COMPLETED
Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux
Lead Sponsor:
GWT-TUD GmbH
Collaborating Sponsors:
Bayer
Conditions:
Superficial Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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-infe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
472 Patients enrolled
Trial Details
Trial ID
NCT01499953
Start Date
April 1 2012
End Date
May 1 2016
Last Update
May 15 2023
Active Locations (23)
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1
Hautarztpraxis
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79098
2
Gemeinschaftspraxis Mietaschk, Bilderling, Kaiser, Tato
München, Bavaria, Germany, 80331
3
Chriurgische Praxisklinik
Baesweiler, North Rhine-Westphalia, Germany, 52499
4
Krankenhaus Dresden-Friedrichstadt
Dresden, Saxony, Germany, 01067