Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis

Last updated: November 24, 2018
Sponsor: Walter Ageno
Overall Status: Active - Recruiting

Phase

3

Condition

Venous Thrombosis

Thrombosis

Venous Thromboembolism

Treatment

N/A

Clinical Study ID

NCT02722447
2016-000958-36
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Objective diagnosis of isolate distal deep vein thrombosis within 72 hours from theevaluation for inclusion in the study and if any type of parenteral treatment wasadministered at therapeutic doses for 3 days or less (maximum accepted doses of lowmolecular weight heparin: 6 doses; of fondaparinux: 3 doses).

Exclusion

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

Study Design

Total Participants: 1100
Study Start date:
January 01, 2017
Estimated Completion Date:
June 30, 2021

Connect with a study center

  • Ospedale di Faenza

    Faenza,
    Italy

    Active - Recruiting

  • Ospedale di Padova

    Padua,
    Italy

    Active - Recruiting

  • Ospedale di Pieve di Soligo

    Pieve di Soligo,
    Italy

    Active - Recruiting

  • Ospedale di Reggio Emilia

    Reggio Emilia,
    Italy

    Active - Recruiting

  • University of Siena

    Siena,
    Italy

    Active - Recruiting

  • Ospedale di Circolo

    Varese, 21100
    Italy

    Active - Recruiting

  • University Of Insubria

    Varese, 21100
    Italy

    Active - Recruiting

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