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| HAL : ujm-00439737, version 1 |
| PubMed : 18946418 |
| Fiche détaillée |  Récupérer au format |
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| Revue des Maladies Respiratoires 25, 7 (2008) 885-93 |
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| [Prolongation of anti vitamin K treatment for 18 months versus placebo after 6 months treatment of a first episode of ideopathic pulmonary embolism: a mutlicentre, randomised double blind trail. The PADIS-EP Trial] |
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| F. Couturaud 1G. Pernod 2 |
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| (09/2008) |
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| BACKGROUND: After stopping a 3 to 6 months course of oral anticoagulation for a first episode of idiopathic venous thromboembolism (VTE), the risk of recurrent VTE is high (10% per year). In this setting, international guidelines recommend at least 6 months treatment. However, this recommendation is not satisfactory for the following reasons: (1) no randomized trial has compared 6 months to extended duration (2 years) anticoagulation; and (2), even though the frequency of recurrent VTE is similar after pulmonary embolism (PE) and deep vein thrombosis (DVT), the fatality rate of recurrent VTE after PE is higher than that after DVT. METHODS: A French multicentre double blind randomized trial. The main objective is to demonstrate, after a first episode of symptomatic idiopathic PE treated for 6 months using a vitamin K antagonist, that extended anticoagulation for 18 months (INR between 2 and 3) is associated with an increased benefit / risk ratio (recurrent VTE and severe anticoagulant-related bleeding) compared to placebo. The double blind evaluation is ensured using by active warfarin and placebo, and blinded INR. The protocol was approved by the ethics board of the Brest Hospital on the 7th of March 2006. For an alpha risk of 5% and a beta risk of 20%, the estimated sample size is 374 patients. EXPECTED RESULTS: This study has the potential to: (1) demonstrate that the benefit / risk ratio of extended anticoagulation for 18 months is higher than that observed with placebo in patients with a first episode of idiopathic PE initially treated for 6 months, during and after the treatment period; and (2) to validate or invalidate the contribution of isotope lung scans, lower limb Doppler ultrasound and D-Dimer at 6 months of treatment as predictors of recurrent VTE (medico-economic analysis included). |
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| 1 : | Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO) |
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Université de Bretagne Occidentale [UBO] |
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| 2 : | Laboratoire d'Hématologie |
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CHU Grenoble |
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| 3 : | Département de médecine aiguë spécialisée |
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CHU Grenoble – Hôpital Michallon |
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| 4 : | Groupe de recherche sur la thrombose (GRT (EA 3065)) |
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Université Jean Monnet - Saint-Etienne |
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| 5 : | Departamento de Matemática Aplicada |
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Facultad de Ciencias – Universidad de Granada |
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| 6 : | Ecole Vétérinaire de Toulouse |
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Ecole Vétérinaire de Toulouse |
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| 7 : | Service de pneumologie [Béclère] |
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Assistance publique - Hôpitaux de Paris (AP-HP) – Hôpital Antoine Béclère – Université Paris XI - Paris Sud |
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| 8 : | Cytokines, chimiokines et immunopathologie |
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INSERM : U764 – IFR13 – Université Paris XI - Paris Sud |
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| 9 : | Service de Biochimie |
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Assistance publique - Hôpitaux de Paris (AP-HP) – Hôpital Lariboisière – IFR6 |
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| 10 : | Fédération de cardiologie |
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Assistance publique - Hôpitaux de Paris (AP-HP) – Hôpital Henri Mondor – Hôpital Albert Chenevier – Université Paris-Est Créteil Val-de-Marne (UPEC) |
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| 11 : | Service de médecine interne |
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Hôpital Sud |
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| 12 : | Protéases et vectorisation pulmonaires |
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INSERM : CIC202 – IFR135 – IFR136 – Université François Rabelais - Tours |
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| 13 : | Littoral, Environnement, Télédétection, Géomatique (LETG - Géolittomer) |
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CNRS : UMR6554 – Université de Bretagne Occidentale [UBO] – Université de Nantes – Université de Caen Basse-Normandie – Université de Rennes II - Haute Bretagne – Université d'Angers |
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| 14 : | Service d'angiologie |
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CHU Grenoble |
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| 15 : | Centre d'Investigation Clinique - Epidemiologie Clinique/essais Cliniques Saint Etienne |
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INSERM : CIE3 – Université Jean Monnet - Saint-Etienne |
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| 16 : | Département de Médecine Interne et Pneumologie [Brest] (DMIP - Brest) |
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CHU Brest |
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| domaine | : | Sciences du Vivant/Sciences pharmaceutiques/Pharmacologie |
| ujm-00439737, version 1 | |
| http://hal-ujm.ccsd.cnrs.fr/ujm-00439737 | |
| oai:hal-ujm.ccsd.cnrs.fr:ujm-00439737 | |
| Contributeur : Patrick Mismetti | |
| Soumis le : Mardi 8 Décembre 2009, 14:49:25 | |
| Dernière modification le : Jeudi 19 Avril 2012, 17:13:13 | |
