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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).
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic recurrent venous thromboembolism | 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Major Bleeding | 6 years | |
| Chronic Thromboembolic Pulmonary Hypertension | 6 years | |
| Post-Thrombotic Syndrome |
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Inclusion Criteria:
Exclusion Criteria:
Participation refused
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idiopathic pulmonary embolism /Idiopathic Proximal Deep Vein Thrombosis
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| Name | Affiliation | Role |
|---|---|---|
| Francis COUTURAUD | CHRU de Brest | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Brest | Brest | 29609 | France | |||
| CHU de Clermont-Ferrand |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| 6 years |
| Clermont-Ferrand |
| France |
| CHU de Grenoble | Grenoble | 38043 | France |
| CH de Lannion | Lannion | France |
| CH de Lorient | Lorient | France |
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
| CHU de Rennes | Rennes | 35023 | France |
| CH St Brieuc | Saint-Brieuc | France |
| CHU de St Etienne | Saint-Etienne | France |
| CHU de Toulouse | Toulouse | France |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013923 | Thromboembolism |