Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis

  • STATUS
    Recruiting
  • days left to enroll
    72
  • participants needed
    1100
  • sponsor
    Walter Ageno
Updated on 22 January 2021
heparin
clot
rivaroxaban
venous thromboembolism
deep vein thrombosis
thromboembolism
blood clot
fondaparinux
venous thrombosis
deep venous thrombosis of lower extremity

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.

Details
Condition Venous Thrombosis, Thrombosis, Blood Clots, Deep Vein Thrombosis, deep venous thrombosis of lower extremity, deep venous thrombosis
Treatment Placebo, Rivaroxaban
Clinical Study IdentifierNCT02722447
SponsorWalter Ageno
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Venous Thrombosis?
Do you have any of these conditions: Venous Thrombosis or Thrombosis or Blood Clots or deep venous thrombosis or Deep Vein Thrombosis or deep venous thrombosis of lower extremity?
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
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