Absence of Residual Vein Thrombosis Permits to Withdrawn Oral Anticoagulants

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera Universitaria Policlinico
• Treatments: Anticoagulants; Warfarin

Criteria

Inclusion Criteria:

• First episode of unprovoked 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,

• Pregnancy

• Conditions requiring anticoagulation (atrial fibrillation, etc)