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Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis

NCT02722447 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2018-11-27

No results posted yet for this 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.

Conditions

  • Deep Vein Thrombosis

Interventions

DRUG

rivaroxaban

Rivaroxaban 20 mg for 6 weeks

DRUG

Placebo

Placebo for 6 weeks

Sponsors & Collaborators

  • Walter Ageno

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-06-30
Completion
2021-06-30

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02722447 on ClinicalTrials.gov