Six Years of Follow-up After Idiopathic Venous Throbmoembolism (Padis-Ext)
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| ClinicalTrials.gov Identifier: NCT02884934 |
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Recruitment Status :
Recruiting
First Posted : August 31, 2016
Last Update Posted : February 22, 2019
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Sponsor:
University Hospital, Brest
Information provided by (Responsible Party):
University Hospital, Brest
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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 |
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| Pulmonary Embolism Proximal Deep Vein Thrombosis |
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. |
| Actual Study Start Date : | March 28, 2013 |
| Estimated Primary Completion Date : | November 2022 |
| Estimated Study Completion Date : | November 2022 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- Symptomatic recurrent venous thromboembolism [ Time Frame: 6 years ]
Secondary Outcome Measures :
- Major Bleeding [ Time Frame: 6 years ]
- Chronic Thromboembolic Pulmonary Hypertension [ Time Frame: 6 years ]
- Post-Thrombotic Syndrome [ Time Frame: 6 years ]
Information from the National Library of Medicine
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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 |
| Other Study ID Numbers: |
Padis-Extension (RB 12.075) |
| First Posted: | August 31, 2016 Key Record Dates |
| Last Update Posted: | February 22, 2019 |
| Last Verified: | February 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Keywords provided by University Hospital, Brest:
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venous thromboembolism recurrent venous thromboembolism anticoagulant-related bleeding |
Additional relevant MeSH terms:
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Pulmonary Embolism Thrombosis Embolism Venous Thrombosis Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |