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Absence of Residual Vein Thrombosis Permits to Withdrawn Oral Anticoagulants

NCT00623987 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2008-03-25

No results posted yet for this study

Summary

Background. The optimal duration of oral anticoagulant treatment in patients with idiopathic Deep Vein Thrombosis (DVT)of the lower limbs is still uncertain. Residual Vein Thrombosis (RVT) has been found able to establish the patient' risk for recurrent thrombotic events. In the present study we conducted a RVT-based therapeutic strategy, withholding OAT after 3 months in patients without RVT while continuing anticoagulants for at least additional 9 months in those in whom RVT persists.

Methods Patients with a first episode of symptomatic unprovoked 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 (Group B), whereas those with RVT will continue OAT for at least additional 9 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 accordingly INR value

warfarin accordingly to INR value between 2.0-3.0

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Policlinico

    lead OTHER

Principal Investigators

  • Sergio Siragusa, MD · University Hospital of Palermo

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-06-30
Primary Completion
2006-06-30
Completion
2008-01-31

Countries

  • Italy

Study Locations

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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 NCT00623987 on ClinicalTrials.gov