drugset / Trial / NCT00438230

Residual Vein Thrombosis Establishes the Optimal Duration of Oral Anticoagulants

NCT00438230

Phase 4 Completed 250 enrolled Azienda Ospedaliera Universitaria Policlinico
RandomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2003-11
Primary completion
Completion
2006-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Warfarin Small molecule Oral