Trial | NCT02722447  Report issue

Official Title

Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    rivaroxaban ...

  • Study Participants

    1100
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 Started
Jan 31
2017
Primary Completion
Jun 30
2019
Anticipated
Study Completion
Jun 30
2021
Anticipated
Last Update
Nov 27
2018

Drug rivaroxaban

Rivaroxaban 20 mg for 6 weeks

Drug Placebo

Placebo for 6 weeks

Rivaroxaban Active Comparator

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)

Placebo Experimental

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)

Criteria 

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
No Results Posted