Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis

Study Overview
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Brief Summary
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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.

Official Title
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Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis

Conditions
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Deep Vein Thrombosis

Intervention / Treatment
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* Drug: rivaroxaban
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rivaroxaban<br>Rivaroxaban 20 mg od for 6 weeks after an initial course of rivaroxaban for 6 weeks (15 mg bid for 3 weeks and 20 mg od for 3 weeks) | Drug: rivaroxaban<br>* Rivaroxaban 20 mg for 6 weeks<br>|
| Experimental: Placebo<br>Placebo for 6 weeks after an initial course of rivaroxaban for 6 weeks (15 mg bid for 3 weeks followed by 20 mg od for 3 weeks) | Drug: Placebo<br>* Placebo for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recurrent venous thromboembolism | Recurrent venous thromboembolism defined as new deep vein thrombosis, extension of distal deep vein thrombosis or pulmonary embolism | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |