Six Years of Follow-up After Idiopathic Venous Throbmoembolism

Completed

• Conditions: Pulmonary Embolism; Proximal Deep Vein Thrombosis

• Registration Number: NCT02884934
• Lead Sponsor: University Hospital, Brest

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2013-03-28
• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-08-31
• Primary Completion: 2023-03-22
• Study Completion: 2023-03-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 409

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptomatic recurrent venous thromboembolism	6 years

Secondary Outcome Measures

Name	Time	Method
Major Bleeding	6 years
Chronic Thromboembolic Pulmonary Hypertension	6 years
Post-Thrombotic Syndrome	6 years

Trial Locations

Locations (10)

CHRU de Brest; 🇫🇷 Brest, France

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CH de Lannion; 🇫🇷 Lannion, France

CH de Lorient; 🇫🇷 Lorient, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

CHU de Rennes; 🇫🇷 Rennes, France

CH St Brieuc; 🇫🇷 St Brieuc, France

CHU de St Etienne; 🇫🇷 St Etienne, France

CHU de Toulouse; 🇫🇷 Toulouse, France