Overview

Residual Vein Thrombosis Establishes the Optimal Duration of Oral Anticoagulants

Status:
Completed

Trial end date:
2006-09-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Azienda Ospedaliera Universitaria Policlinico

Treatments:

Anticoagulants
Warfarin

Criteria

Inclusion Criteria:

- First episode of unprovoked and provoked proximal DVT of the lower limbs and treated
for 3 month with oral anticoagulants

Exclusion Criteria:

- Active cancer,

- Limited life expectancy,

- Antiphospholipid antibody syndrome, or an other known thrombophilic status (such as
antithrombin deficiency),

- Serious liver disease,

- Renal insufficiency (serum creatinine > 2 mg/dL).