UnknownPhase 3

Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis

Italy1,100 participantsStarted 2017-01

Plain-language summary

The treatment of isolated distal deep vein thrombosis remains one of the most debated issues in the field of venous thromboembolism and only very few studies have directly addressed the issue of treatment in objectively confirmed isolated distal deep vein thrombosis. Aim of this study is to assess the long-term risk of recurrent venous thrombotic events in patients with a first acute symptomatic isolated distal deep vein thrombosis of the leg treated with a standard (12 weeks) or with a shorter (6 weeks) duration of therapy with rivaroxaban.

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: * Objective diagnosis of isolate distal deep vein thrombosis within 72 hours from the evaluation for inclusion in the study and if any type of parenteral treatment was administered at therapeutic doses for 3 days or less (maximum accepted doses of low molecular weight heparin: 6 doses; of fondaparinux: 3 doses). Exclusion Criteria: * Age \< 18 years * Any absolute contraindication to anticoagulant treatment * Pregnancy or breast-feeding * Presence of active cancer * Concomitant presence of proximal deep vein thrombosis or pulmonary embolism * Any concomitant indication for long-term anticoagulant treatment * Creatinine clearance ≤30 ml/min, according to Cockcroft-Gault equation * Cirrhosis Child-Pugh score B or C * Liver disease associated with coagulopathy and high risk of bleeding * Any other contraindication to rivaroxaban as per local SmPC * Failure to provide written informed consent

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.

What they're measuring

Rate of recurrent venous thromboembolism

Timeframe: 24 months

Trial details

NCT IDNCT02722447

SponsorWalter Ageno

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06

Contact for this trial

Lorenza Bertù, PhD

0039 0332 278831 lorenza.bertu@uninsubria.it

View on ClinicalTrials.gov More Deep Vein Thrombosis trials