Clinical trial NCT02884934: Six Years of Follow-up After Idiopathic Venous Throbmoembolism
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Proximal Deep Vein Thrombosis
Keywords: venous thromboembolism
recurrent venous thromboembolism
anticoagulant-related bleeding
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 409
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: idiopathic pulmonary embolism /Idiopathic Proximal Deep Vein Thrombosis

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptomatic recurrent venous thromboembolism
timeFrame: 6 years
Secondary outcomes:
measure: Major Bleeding
timeFrame: 6 years
measure: Chronic Thromboembolic Pulmonary Hypertension
timeFrame: 6 years
measure: Post-Thrombotic Syndrome
timeFrame: 6 years
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lannion
country: France
facility: CH de Lannion
city: Lorient
country: France
facility: CH de Lorient
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Rennes
country: France
facility: CHU de Rennes
city: St Brieuc
country: France
facility: CH St Brieuc
city: St Etienne
country: France
facility: CHU de St Etienne
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: CHRU de Brest
name: Francis COUTURAUD
role: STUDY_DIRECTOR
References: