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 range
18 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.