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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,100
Rivaroxaban 20 mg for 6 weeks
Placebo for 6 weeks
Ospedale di Faenza
Faenza, Italy
RECRUITINGOspedale di Padova
Padua, Italy
RECRUITINGOspedale di Pieve di Soligo
Pieve di Soligo, Italy
Rate of recurrent venous thromboembolism
Recurrent venous thromboembolism defined as new deep vein thrombosis, extension of distal deep vein thrombosis or pulmonary embolism
Time frame: 24 months
Rate of major bleeding events
Time frame: Until 2 days from the last intake of the study drug
Rate of clinically relevant non-major bleeding events
Time frame: Until 2 days from the last intake of the study drug
Percentage of patients with residual vein occlusion
Time frame: 3 months and 24 months
Rate of cardiovascular events
Time frame: 24 months
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Ospedale di Reggio Emilia
Reggio Emilia, Italy
RECRUITINGUniversity of Siena
Siena, Italy
RECRUITINGOspedale di Circolo
Varese, Italy
RECRUITINGUniversity Of Insubria
Varese, Italy
RECRUITING