Status:
COMPLETED
Prolonged Anticoagulation After a First Episod of Idiopathic Proximal Deep Vein Thrombosis (PADIS TVP)
Lead Sponsor:
University Hospital, Brest
Conditions:
Recurrent Venous Thromboembolism
Idiopathic Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
Rational: After 3 or 6 months of oral anticoagulation for an episode of acute venous thromboembolism (VTE), the risk of recurrent VTE is high (10 to 15% per year) in comparison with a low risk of recu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00740493
Start Date
July 1 2007
End Date
January 1 2017
Last Update
January 12 2017
Active Locations (14)
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1
CHRU de Brest
Brest, France, 29609
2
CHU de Grenoble
Grenoble, France, 38043
3
Centre Hospitalier Pierre Le Damany
Lannion, France, 22303
4
Centre Hospitalier de Bretagne Sud
Lorient, France, 56322