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Six Years of Follow-up After Idiopathic Venous Throbmoembolism (Padis-Ext)

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ClinicalTrials.gov Identifier: NCT02884934
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease
Pulmonary Embolism Proximal Deep Vein Thrombosis

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 Type : Observational
Estimated Enrollment : 748 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : March 2013
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Symptomatic recurrent venous thromboembolism [ Time Frame: 6 years ]

Secondary Outcome Measures :
  1. Major Bleeding [ Time Frame: 6 years ]
  2. Chronic Thromboembolic Pulmonary Hypertension [ Time Frame: 6 years ]
  3. Post-Thrombotic Syndrome [ Time Frame: 6 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
idiopathic pulmonary embolism /Idiopathic Proximal Deep Vein Thrombosis
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884934


Contacts
Contact: Francis COUTURAUD francis.couturaud@chu-brest.fr

Locations
France
CHRU de Brest Recruiting
Brest, France, 29609
Contact: Francis Couturaud         
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France
Contact: Jeannot Schmidt         
CHU de Grenoble Recruiting
Grenoble, France, 38043
Contact: Gilles Pernod         
CH de Lannion Recruiting
Lannion, France
Contact: Karine Provost         
CH de Lorient Recruiting
Lorient, France
Contact: Serge Baleynaud         
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: Pierre Pottier         
Hôpital Européen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Guy Meyer         
AP-HP Kremlin Bicetre Recruiting
Paris, France
Contact: Florence Parent         
Hotel Dieu Recruiting
Paris, France
Contact: Christine Lorut         
CHIC Quimper Recruiting
Quimper, France
Contact: Rémy Brenard         
CHU de Rennes Recruiting
Rennes, France, 35023
Contact: Patrick Jego         
CH St Brieuc Recruiting
St Brieuc, France
Contact: Duhamel         
CHU de St Etienne Recruiting
St Etienne, France
Contact: Patrick Mismetti         
CHU de Toulouse Recruiting
Toulouse, France
Contact: Alexandra Bura-Riviere         
CHU de Tours Recruiting
Tours, France, 37000
Contact: Yves GRUEL         
Sponsors and Collaborators
University Hospital, Brest
Investigators
Study Director: Francis COUTURAUD CHRU de Brest

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02884934     History of Changes
Other Study ID Numbers: Padis-Extension (RB 12.075)
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Brest:
venous thromboembolism
recurrent venous thromboembolism
anticoagulant-related bleeding

Additional relevant MeSH terms:
Thrombosis
Embolism
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Anticoagulants