Deep Vein Thrombosis
Conditions
Brief 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.
Interventions
DRUGrivaroxaban
Rivaroxaban 20 mg for 6 weeks
DRUGPlacebo
Placebo for 6 weeks
Sponsors
Walter Ageno
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of recurrent venous thromboembolism | 24 months | Recurrent venous thromboembolism defined as new deep vein thrombosis, extension of distal deep vein thrombosis or pulmonary embolism |
Secondary
| Measure | Time frame |
|---|---|
| Rate of major bleeding events | Until 2 days from the last intake of the study drug |
| Rate of clinically relevant non-major bleeding events | Until 2 days from the last intake of the study drug |
| Percentage of patients with residual vein occlusion | 3 months and 24 months |
| Rate of cardiovascular events | 24 months |
Countries
Italy
Contacts
Primary ContactLorenza Bertù, PhD
Outcome results
None listed