Prolonged Anticoagulation After a First Episod of Idiopathic Proximal Deep Vein Thrombosis (PADIS TVP)

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

In a French multicenter double blind randomized controlled trial, the main objective is to demonstrate that, after 6 months of oral anticoagulation for a first episode of idiopathic proximal deep vein thrombosis, 18 months of warfarin therapy is associated with a lower cumulative risk of recurrent VTE and major bleeding in comparison with that on 18 months of placebo. The secondary objectives are: (1) to determine the risk of recurrent VTE after 6 months of warfarin therapy and the presence or the absence of residual lung scan perfusion defect and the persistence or not of elevated D-dimer test; and (2), to determine the impact of extended duration of anticoagulation on the risk of VTE after stopping anticoagulant therapy on a follow-up of 2 years.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Brest
• Treatments: Warfarin

Criteria

Inclusion Criteria:

• Patients with a first episode of idiopathic proximal deep vein thrombosis who have been treated during 6 months (Plus or minus 15 days) using Vitamin K antagonist with a INR between 2 and 3.

Exclusion Criteria:

• Age > 18

• warfarin hypersensibility

• unwilling or unable to give writting informed consent

• distal deep vein thrombosis or pulmonary embolism

• Proximal deep vein thrombosis which was provoked by a reversible major risk factor

• major thrombophilia (protein C, S or antithrombin deficiency, antiphospholipids antibodies, homozygous factor V Leiden)

• previous documented episode of proximale deep vein thrombosis or pulmonary embolism

• other indication for anticoagulant therapy (e.g.:atrial fibrillation, mechanic valve)

• patient on antithrombotic agent in whom antithrombotic agent should be started again after stopping anticoagulation

• pregnancy

• women without contraception

• planned major surgery in the next 18 months

• ongoing cancer or cured cancer in less than 2 years

• serious bleeding risk (e.g.: gastric ulcer)

• platelet count less than 100 Giga/l

• Life expectancy less than 18 months