Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux (NCT01499953) | Clinical Trial Compass
CompletedPhase 3
Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux
Germany472 participantsStarted 2012-04
Plain-language 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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 clinicall…