Six Years of Follow-up After Idiopathic Venous Throbmoembolism

Pulmonary Embolism Clinical Trial

— Padis-Ext  

Official title:

Six Years of Follow-up After Extended Duration of Oral Anticoagulant Therapy for a First Episode of Idiopathic Pulmonary Embolism or Proximal Deep Vein Thrombosis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02884934
• Other study ID #: Padis-Extension (RB 12.075)
• Status: Recruiting
• Start date: March 28, 2013
• Est. completion date: November 2023

Study information

• Verified date: October 2022
• Source: University Hospital, Brest
• Contact: Francis COUTURAUD
• Email: francis.couturaud[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 748
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Proximal Deep Vein Thrombosis
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
France	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	CHU de Nantes	Nantes
France	AP-HP Kremlin Bicetre	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Hotel Dieu	Paris
France	CHIC Quimper	Quimper
France	CHU de Rennes	Rennes
France	CH St Brieuc	St Brieuc
France	CHU de St Etienne	St Etienne
France	CHU de Toulouse	Toulouse
France	CHU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic recurrent venous thromboembolism		6 years
Secondary	Major Bleeding		6 years
Secondary	Chronic Thromboembolic Pulmonary Hypertension		6 years
Secondary	Post-Thrombotic Syndrome		6 years