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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000315-24 | EudraCT Number |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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The treatment of the venous thromboembolic disease, including pulmonary embolism (PE), is based on anticoagulants. During the last decade, all the randomized clinical trials evaluating these anticoagulants have included PE patients with an average age below 60 years. But in clinical pratice, approximately 50% of PE patients are older than 75 years.
So the investigators want to perform a french multicentre prospective cohort of consecutive patients receiving an anticoagulant treatment for a symptomatic and confirmed PE. All the validated and available anticoagulant treatments are authorized in this cohort (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and direct oral anticoagulants).
This cohort will provide data regarding the bleeding risk and the risk of PE recurrences and regarding the pharmacokinetic (PK) and pharmacodynamic (PD) properties of these anticoagulants in this older population. Using population approach modelling , the investigators will pay particular attention to the sources of PK/PD variability PK / PD such as genetic polymorphisms of P-glycoprotein and cytochrome P450.
Using all these data , the investigators will try to identify significant risk factors for bleeding and venous thromboembolic events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEAGE | Patients older than 75 years receiving an anticoagulant treatment for a symptomatic and confirmed PE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 blood samples | Other | PK and / or PD measurements during hospitalization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding defined by the International Society of Thrombosis & Haemostasis |
| at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically relevant non-major bleeding | defined by:
| at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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patients older than 75 years receiving an anticoagulant treatment (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and direct oral anticoagulants) for a symptomatic and confirmed pulmonary embolism
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| Name | Affiliation | Role |
|---|---|---|
| Patrick MISMETTI, MD PhD | CHU de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Angers | 49033 | France | |||
| Hôpital Universitaire Jean Minjoz |
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| Recurrent pulmonary embolism | confirmed by CT scan or ventilation/perfusion lung scan | at 6 months |
| Deep vein thrombosis (recurrence or new) | confirmed by venous doppler ultrasonography or venography of the lower limbs or CT scan | at 6 months |
| Arterial cardiovascular events |
| at 6 months |
| Death | at 6 months |
| Besançon |
| 25000 |
| France |
| CHU de Brest | Brest | 29609 | France |
| Clinique du Parc - Castelnau Le Lez | Castelnau-le-Lez | 34170 | France |
| CHU Gabriel Montpied | Clermont-Ferrand | 63003 | France |
| Hôpitaux Universitaires Louis Mourier Paris Nord | Colombes | 92700 | France |
| CHU de Dijon | Dijon | 21079 | France |
| CHU de Grenoble | Grenoble | 38043 | France |
| CHU de Limoges | Limoges | 87000 | France |
| CHU de Montpellier | Montpellier | 34295 | France |
| CHRU de Nantes | Nantes | 44093 | France |
| CHU de Nice | Nice | 06002 | France |
| Hôpital Europeen Georges Pompidou, APHP | Paris | 75015 | France |
| APHP Hôpital BROCA | Paris | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69310 | France |
| CHU de Rouen | Rouen | 76000 | France |
| CHU de Saint Etienne | Saint-Etienne | 42055 | France |
| CHU de Strasbourg - Hôpital Civil | Strasbourg | 67000 | France |
| Centre Hospitalier Intercommunal Toulon La Seyne sur Mer | Toulon | 83056 | France |
| CHU Tours | Tours | 37000 | France |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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