Six Years of Follow-up After Idiopathic Venous Throbmoembolism

  • STATUS
    Recruiting
  • End date
    Nov 22, 2022
  • participants needed
    748
  • sponsor
    University Hospital, Brest
Updated on 22 January 2021
Investigator
Site Coordinator
Primary Contact
CHU de St Etienne (2.4 mi away) Contact
+12 other location
thrombosis
clot
anticoagulants
vitamin k antagonist
anticoagulant therapy
vitamin k
venous thromboembolism
deep vein thrombosis
thromboembolism
blood clot
anticoagulation therapy

Summary

Beyond the first 6 months of anticoagulation, patients with a first episode of unprovoked venous thromboembolism have a high risk of recurrence after stopping anticoagulations. Extending anticoagulant therapy for an additional 18 months is associated with a major reduction of recurrent VTE; however this benefit tended to be lost after stopping anticoagulation during a follow-up period of two years. This risk of recurrentce is likely to continuously increase over the years as well as the risk of chronic thromboembolic pulmonary hypertension (after pulmonary embolism) or the risk of post-thrombotic syndrome (after deep vein thrombosis). The aim of the PADIS-EXTENSION trial is to estimate these risks over 6 years of follow-up in patients who have been initially treated during 6 months or 24 months (patients included in the PADIS PE and PADIS DVT trial).

Description

Beyond the first 6 months of anticoagulation, patients with a first episode of unprovoked venous thromboembolism have a high risk of recurrence after stopping anticoagulations (about 10% at one year and 30% at 5 years). Extending anticoagulant therapy for an additional 18 months is associated with a major reduction of recurrent VTE; however this benefit tended to be lost after stopping anticoagulation during a follow-up period of two years. This has been well demonstrated in the double-blind randomized PADIS PE trial comparing 2 years with 6 months of anticoagulation and a follow-up of two years after study treatment discontinuation. This risk of recurrence is likely to continuously increase over the years as well as the risk of chronic thromboembolic pulmonary hypertension (after pulmonary embolism) or the risk of post-thrombotic syndrome (after deep vein thrombosis). In addition, risk factors of such complications remain uncertain. The first aim of the PADIS-EXTENSION trial is to estimate these risks over 6 years of follow-up in patients who have been initially treated during 6 months or 24 months (patients included in the PADIS PE and PADIS DVT trial). Secondary aims are to identify risk factors of these complications during long-term follow-up.

Details
Condition Pulmonary Disease, Pulmonary Embolism, Proximal Deep Vein Thrombosis, Lung Disease, lung embolism
Clinical Study IdentifierNCT02884934
SponsorUniversity Hospital, Brest
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with a first episode of idiopathic pulmonary embolism or idiopathic proximal deep vein thrombosis who have been initially treated during 6 months or 24 months using Vitamin K antagonist with a INR between 2 and 3 and enrolled in clinical study Padis-Ep and Padis TVP

Exclusion Criteria

Participation refused
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