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Residual Vein Thrombosis Establishes the Optimal Duration of Oral Anticoagulants

NCT00438230 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2007-02-22

No results posted yet for this study

Summary

ABSTRACT Background The optimal duration of oral anticoagulant treatment in patients with idiopathic venous thromboembolism is still uncertain . The present study addressed the possible role of the Residual Vein Thrombosis in assessing the need for a prolonged anticoagulation.

Methods Patients with a first episode of symptomatic unprovoked or provoked proximal Vein Thrombosis (VT) were given Oral Anticoagulant Treatment (OAT) for 3 months. Residual Vein Thrombosis (RVT), ultrasonographically-detected, will be then assessed. Patients without RVT did not continue OAT, whereas those with RVT will be randomized to either stop or continue OAT for 9 more months. Patients were followed-up prospectively focusing on the study outcomes: occurrence of recurrent venous thromboembolism and major bleeding over a period of at least 12 months after OAT discontinuation.

Conditions

  • Deep Vein Thrombosis

Interventions

DRUG

Warfarin

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Policlinico

    lead OTHER

Principal Investigators

  • Sergio Siragusa, MD · University Hospital of Palermo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Completion
2006-09-30

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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 NCT00438230 on ClinicalTrials.gov